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Diphen


SPL UNCLASSIFIED SECTION

REMEDY PACK


SPL UNCLASSIFIED SECTION

Burn Cream

Drug Facts


INGREDIENTS


Active ingredients

Benzalkonium Chloride 0.13%, Lidocaine HCl 0.5%


Purpose

Topical antiseptic, Topicall analgesic


USES

First aid to help prevent infection in minor cuts, scrapes and burns.

For the temporary relief of pain and itching associated with:

  • sunburn
  • insect bites
  • cuts
  • minor skin irritations
  • scrapes
  • minor burns

WARNING

For external use only.


Do not use

  • in the eyes
  • over large areas of the body or on deep puncture wounds, animal bites, or serious burns
  • in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask doctor if

  • the condition gets worse
  • condition clears up and recurs within a few days
  • condition persists for more than 7 days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding, ask a health care professional before use.


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.


DIRECTIONS

Adults and children 2 years and over:

  • clean the affected area
  • apply a small amount of this product on the area 3 to 4 times daily
  • may be covered with a sterile bandage
  • Children under 12 years: consult a doctor
  • Children under 2 years: consult a doctor

OTHER INFORMATION

  • store in a cool, dry area 59° to 79°F (15° to 25°C)
  • tamper evident sealed packets
  • do not use any opened or torn packets

INACTIVE INGREDIENTS

decolorized aloe vera, emulsifying wax, ethyl alcohol, methylparaben, mineral oil, paraffin, propylparaben, purified water, white petrolatum, white wax


SPL UNCLASSIFIED SECTION

Triple Antibiotic

Drug Facts


INGREDIENTS


Active Ingredient (in each gram)

Bacitracin zinc (400 units), Neomycin sulfate 5 mg (equivalent to 3.5 mg of Neomycin), Polymyxin-B sulfate 5000 units


Purposes

First aid antibiotics


USES

First aid to help prevent infection in:

  • minor cuts
  • scrapes
  • burns

WARNING

  • For external use only

Do not use

  • in the eyes
  • over large areas of the body if you are allergic to any of the ingredients longer than 1 week unless directed by a doctor

Ask a doctor before use

in case of deep or puncture wounds, animal bites, or serious burns


Stop use and ask a doctor if

the condition persists or gets worse a rash or other allergic reaction develops


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.


DIRECTIONS

clean the affected area apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily may be covered with a sterile bandage


OTHER INFORMATION

  • store at room temperature 15°C to 30°C (59°F to 86°F) (do not freeze) tamper evident. Do not use if packet is torn, cut or opened.
  • avoid excessive heat and humidity

INACTIVE INGREDIENTS

mineral oil, white petrolatum


SPL UNCLASSIFIED SECTION

Hydrocortisone Cream

Drug Facts


INGREDIENTS


Active Ingredient (in each gram)

Hydrocortisone 1.0%


Purpose

Anti-Itch


USES

Other uses of this product should only be under the advice and supervision of a doctor.

  • eczema
  • insect bites
  • poison ivy
  • Poison oak
  • poison sumac
  • Cosmetics
  • jewelry
  • soaps detergents
  • seborrheic
  • dermatitis
  • Psoriasas

WARNING

  • For external use only
  • avoid contact with the eyes
  • if condition worsens, or symptoms persist for more than 7 days or clear up and occur again within a few days, stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor

OTC - DO NOT USE SECTION

  • do not use for the treatment of diaper rash.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children.
  • If swallowed, get medical help or consult a poison control center right away.

DIRECTIONS

Adult and children (2 years and over): apply to affected not more than 3 to 4 times daily

Children under 2 years: Consult a doctor.


OTHER INFORMATION

  • store at room temperature 59-86ºF (15-30ºC)
  • do not freeze
  • do not use any opened or torn packets.

INACTIVE INGREDIENTS

emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white Wax.


SPL UNCLASSIFIED SECTION

Oral Pain Relief Gel

Drug Facts


INGREDIENTS


Active ingredients

Benzocaine 20%


Purpose

Oral Anesthetic


USES

For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.


METHEMOGLOBINEMIA WARNING

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood.

This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

  • pale, gray, or blue colored skin (cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy

ALLERGY ALERT

do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other " caine" anesthetics.


Do not use

For more than 7 days unless directed by a physician. If sore mouth symptoms do not improve in 7 days; irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your physician promptly.

  • for teething
  • in children under 2 years of age

When using this product

avoid contact with eyes. If it occurs, flush with water.


SPL UNCLASSIFIED SECTION

Do not exceed recommended dosage.

  • If more than used for pain is accidently swallowed, get medical help or contact a Poison Control Center right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • If pregnant or breast feeding,ask a health care professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children.

DIRECTIONS

  • Apply only amount needed to the oral mucosa to prevent or relieve pain.
  • children under 2 years of age: do not use

OTHER INFORMATION

  • store at room temperature 15°C to 30°C (59°F to 86°F)
  • protect from freezing

INACTIVE INGREDIENTS

Flavoring, PEG 3350, PEG 400, sodium sacchrin, water.

May contain blue #1, green #3, green #5 , red #3, red #28, red #40, yellow #5, (tartrazine), yellow #6, as color additive.


SPL UNCLASSIFIED SECTION

Alcalak

Drug Facts


INGREDIENTS


Active ingredient (in each tablet)

Calcium Carbonate 420mg


Purpose

Antacid


INACTIVE INGREDIENTSmay contain

aspartame, croscarmellose sodium, gum acacia, magnesium stearate, maltodextrin, mineral oil, mint flavor, sorbitol, sucrose


USES

For the relief of the following symptoms associated with

  • acid indigestion
  • sour stomach
  • heartburn
  • upset stomach

WARNING


Do not use

  • the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician, or take more than 19 tablets in a 24 hour period.

Ask a doctor or pharmacist before use if you are

  • presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Stop use and ask a doctor if

  • symptoms last more than 2 weeks

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.


DIRECTIONS

Adults and children: (12 years and older) Chew 2 tablets every 2 or 3 hours as symptoms occur or as directed by a physician. Do not exceed 19 tablets in 24 hours.

Children under 12 years: Do not give to children under 12 years of age.

  • do not use more than directed

OTHER INFORMATION

  • Phenylketonurics: contains phenylalanine 1.5mg per tablet
  • each tablet contains 168mg of elemental calcium
  • store at room temperature 59º-86ºF (15º-30ºC) in a dry place
  • tamper-evident sealed packets
  • do not use any opened or torn packets

SPL UNCLASSIFIED SECTION

Cold Relief

Drug Facts


INGREDIENTS


OTC - PURPOSE SECTION

Active ingredient (in each tablet): Acetaminophen 325mgPurpose: Pain reliever/ fever reducer
Active ingredient (in each tablet): Dextromethorphan Hydrobromide 15mgPurpose: Cough suppressant
Active ingredient (in each tablet): Guaifenesin 200mgPurpose: Expectorant
Active ingredient (in each tablet): Phenylephrine HCl 5mgPurpose: Nasal decongestant

INACTIVE INGREDIENTS*

maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, starch, stearic acid


USES

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies

Temporarily reduces fever.

  • cough
  • sore throat
  • minor aches and pains
  • headache
  • nasal congestion
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

WARNING


Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4,000mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert

Acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

  • skin reddening
  • blisters
  • rash

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you have ever had an allergic reaction to this product or any of the ingredients.
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough that lasts as occurs with smoking, asthma, chronic bronchitis or emphysema

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin

When using this product

  • do not use more than directed

Stop use and ask a doctor if

These could be signs of a serious condition.

  • new symptoms occur
  • redness or swelling is present
  • pain or nasal congestion gets worse or lasts for more than 7 days
  • fever gets worse or lasts for more than 3 days
  • you get nervous, dizzy or sleepless
  • cough comes back or occurs with rash or headache that lasts.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


DIRECTIONS

Adults and children: (12 years and older) Take 2 tablets with water every 6- 8 hours as needed. Do not take more than 8 tablets in 24 hours.

Children under 12 years: Do not give to children under 12 years of age.


OTHER INFORMATION

  • store at room temperature 59º-86ºF (15º-30ºC)
  • avoid excessive heat and humidity
  • tamper-evident sealed packets
  • do not use any opened or torn packets

SPL UNCLASSIFIED SECTION

Medi-Meclizine

Drug Facts


INGREDIENTS


Active ingredient (in each tablet)

Meclizine Hydrochloride 25mg


Purpose

Antiemetic


INACTIVE INGREDIENTS*

anhydrous lactose, colloidal silicon dioxide, corn starch, D&C yellow #10, magnesium stearate, microcrystalline cellulose, sodium starch glycolate


USES

For the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness.

For the reduction of fever.


WARNING


Do not use

  • for children under 12 years of age unless directed by a doctor
  • for frequent or prolonged use except under the advice of a doctor

Ask a doctor before use if you have

  • breathing problems such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland if you are
  • taking sedatives or tranquilizers

When using this product

Do not exceed recommended dosage.

  • drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • avoid alcoholic beverages while taking this product
  • use caution when driving a motor vehicle or operating machinery

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.


DIRECTIONS

Adults and children: (12 years and older) 1 to 2 tablets once daily or as directed by a doctor. Do not exceed 2 tablets in 24 hours.

Children under 12 years: Do not give to children under 12 years of age.

  • do not use more than directed
  • to prevent motion sickness, take the first dose one hour before starting activity

OTHER INFORMATION

  • store at room temperature 59- 86º F (15-30ºC)
  • tamper-evident sealed packets
  • do not use any opened or torn packets

SPL UNCLASSIFIED SECTION

I-Prin

Drug Facts


INGREDIENTS


Active ingredient (in each tablet)

Ibuprofen (NSAIDnonsteroidal anti-inflammatory drug) 200mg


Purpose

Pain reliever/fever reducer


INACTIVE INGREDIENTSmay contain

carnauba wax, corn starch, hypromellose, iron oxide red, lactose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polyvinyl alcohol, povidone (K-30), silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide


USES

Temporarily relieves minor aches and pains associated with

Temporarily reduces fever.

  • headache
  • toothache
  • backache
  • menstrual cramps
  • common cold
  • muscular aches
  • minor arthritis pain

WARNING


Allergy alert

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.

Symptoms may include:

If an allergic reaction occurs, stop use and seek medical help right away.

  • hives
  • skin reddening
  • facial swelling
  • rash
  • asthma (wheezing)
  • blisters
  • shock

Stomach bleeding warning

This product contains an NSAID, which may cause severe stomach bleeding.

The chance is higher if you:

Heart attack or stroke warning: NSAIDS, except aspirin, increase the risk of heart attack, heart failure, and stroke.

These can be fatal. The risk is higher if you use more than directed or for longer than directed.

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Do not use

  • if you have ever had an allergic reaction to any other pain reliever/ fever reducer
  • right before or after heart surgery

Ask a doctor before use if

  • you have problems or serious side effects from taking pain relievers or fever reducers
  • stomach bleeding warning applies to you
  • you have a history of stomach problems such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma or had a stroke
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are

  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • under a doctor's care for any serious condition
  • taking any other drug

When using this product

  • take with food or milk if stomach upset occurs

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:- feel faint- vomit blood- have bloody or black stools- have stomach pain that does not get better
  • you have symptoms of heart problems or stroke- chest pain- trouble breathing- weakness in one part or side of body- slurred speech- leg swelling
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • any new or unexpected symptoms occur

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.


DIRECTIONS

Adults and children: (12 years and older) Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor.

Children under 12 years: Do not give to children under 12 years of age.

  • do not take more than directed
  • the smallest effective dose should be used
  • do not take longer than 10 days, unless directed by a doctor (see Warnings)

OTHER INFORMATION

  • read all product information before using
  • store at 68-77°F (20-25°C)
  • avoid excessive heat 104°F (above 40°C)
  • tamper-evident sealed packets
  • do not use any opened or torn packets

SPL UNCLASSIFIED SECTION

Diphen

Drug Facts


INGREDIENTS


Active ingredient (in each tablet)

Diphenhydramine HCl 25mg


Purpose

Antihistamine


INACTIVE INGREDIENTSmay contain

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, titanium dioxide


USES


Active ingredients

Diphenhydramine HCl 25mg


Purpose

Antihistamine


Inactive Ingredientsmay contain

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, titanium dioxide


WARNING


Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one that is used on skin

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland
  • glaucoma

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers

When using this product

  • marked drowsiness may occur
  • avoid alcohol beverages
  • alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • use caution when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center immediately.


DIRECTIONS

Adults and children: (12 years and older) Take 1 to 2 caplets every 4 to 6 hours as needed. Do not take more than 12 caplets in 24 hours, or as directed by a doctor.

Children under 12 years: Do not give to children under 12 years of age.

  • do not use more than directed

OTHER INFORMATION

  • each caplet may contain: calcium 25mg
  • protect from light
  • use by expiration date on packet
  • store at room temperature 59º-86ºF (15º-30ºC)
  • tamper-evident sealed packets
  • do not use any opened or torn packets

SPL UNCLASSIFIED SECTION

Extra Strength APAP

Drug Facts


INGREDIENTS


Active ingredient (in each tablet)

Acetaminophen 500mg


Purpose

Pain reliever/fever reducer


INACTIVE INGREDIENTSmay contain

corn starch, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide


USES

For the temporary relief of minor aches and pains associated with

For the reduction of fever.

  • headache
  • muscular aches
  • minor arthritis pain
  • common cold
  • toothache
  • menstrual cramps

WARNING


Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 8 tablets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert

Acetaminophen may cause severe skin reactions.

Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

  • skin reddening
  • blisters
  • rash

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor

Ask a doctor before use if you have

  • liver disease

Ask a doctor or pharmacist before use if

  • you are taking the blood thinning drug warfarin

Stop using and ask a doctor if

  • symptoms do not improve
  • new symptoms occur
  • pain or fever persists or gets worse
  • redness or swelling is present

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


DIRECTIONS

Adults and children: (12 years and older) Take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.

Children under 12 years: Do not give this adult strength product to children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

  • do not use more than directed

OTHER INFORMATION

  • store at room temperature 59º-86ºF (15º-30ºC)
  • tamper-evident sealed packets
  • do not use any opened or torn packets

SPL UNCLASSIFIED SECTION

Loradamed

Drug Facts


INGREDIENTS


Active ingredient (in each tablet)

Loratadine 10mg


Purpose

Antihistamine


INACTIVE INGREDIENTS*

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch


USES

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies

  • runny nose
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat

WARNING


OTC - DO NOT USE SECTION

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.


OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.


OTC - WHEN USING SECTION

When using this product do not take more than directed. Taking more than directed may cause drowsiness.


Stop use and ask a doctor if

  • an allergic reaction to this product occurs. Seek medical help right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


DIRECTIONS

Adults and children: (12 years and older) Take 1 tablet daily; not more than 1 tablet in 24 hours.

Children under 12 years: Do not give to children under 12 years of age.

Consumers with liver or kidney disease: Ask a doctor before using.


OTHER INFORMATION

  • store at room temperature 68º-77ºF (20º-25ºC)
  • protect from excessive moisture
  • tamper-evident sealed packets
  • do not use any opened or torn packets

SPL UNCLASSIFIED SECTION

Medi-Lyte

Drug Facts


INFORMATION

Serving Size: 2 tablets

Servings Per Packet: 1


OTHER INGREDIENTS

microcrystalline cellulose, silicon dioxide, stearic acid, magnesium stearate


OTC - ACTIVE INGREDIENT SECTION

Calcium (from 27.0 mg calcium carbonate) 10.8 mg1.06%
Potassium (from 80 mg potassium chloride) 40mg1.15%
Magnesium (from 20 mg magnesium oxide) 12 mg3.0%
Carbohydrates 6 mg>1%
Calories 1.5>1%
Protein0%
Fat0%

USES

Nutritional support for the following symptoms due to excessive loss of perspiration

*This statement has not been evaluated by the Food and Drug administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

  • heat fatigue
  • muscle cramps
  • heat exhaustion
  • heat stroke
  • replaces lost electrolytes
  • helps provide rapid rehydration

WARNING


OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.


DIRECTIONS

Adults and children: (12 years and older)

Children under 12 years:

  • take 2 tablets as needed with a full glass of water
  • may be repeated every hour as needed
  • do not exceed 20 tablets in 24 hours

OTHER INFORMATION

  • store at room temperature 59º-86º F (15º-30º C)
  • avoid excessive heat and humidity
  • tamper-evident sealed packets
  • do not use any opened or torn packets
  • no sodium added

SPL UNCLASSIFIED SECTION

Diotame

Drug Facts


INGREDIENTS


Active ingredient (in each tablet)

Bismuth Subsalicylate 262mg (each tablet contains 102mg salicylate)


Purpose

Upset stomach reliever/antidiarrheal


INACTIVE INGREDIENTS*

acacia gum, aspartame, calcium carbonate, D&C red #27, dextrates, flavoring, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide


USES

Temporarily relieves

  • travelers' diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including-heartburn-indigestion-nausea-gas-belching-fullness

WARNING


Reye's syndrome

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's Syndrome a rare but serious illness.


Allergy alert

Contains salicylate. Do not take if you are:

  • allergic to salicylates (including aspirin)
  • taking other salicylate products

Do not use if you have

  • bloody or black stool
  • an ulcer
  • a bleeding problem

Ask a doctor before use if you have

  • fever
  • mucus in the stool

Ask a doctor or pharmacist if you are taking any drug for

  • anticoagulation (thinning of the blood)
  • diabetes
  • gout
  • arthritis

Stop use and ask a doctor if

  • symptoms get worse
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days

OTC - WHEN USING SECTION

When using this product a temporary and harmless darkening of the tongue and/or stool may occur. Stool darkening should not be confused with melena.


OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of reach of children. In case of accidental overdose, contact a physician or poison control center immediately.


DIRECTIONS

Adults and children: (12 years and older) Chew 2 tablets every 1/2 to 1 hour or 4 tablets every hour as needed.

Children under 12 years: Do not give to children under 12 years of age.

  • do not use more than directed
  • chew or crush tablets completely before swallowing
  • do not swallow tablets whole
  • use until diarrhea stops but not more than 2 days
  • drink plenty of clear fluids to help prevent dehydration, which may accompany diarrhea
  • do not exceed 16 tablets in 24 hours

OTHER INFORMATION

  • Phenylketonurics: contains phenylalanine 1.1mg per tablet
  • each tablet contains 73mg of elemental calcium
  • store at room temperature 59º-86ºF (15º-30ºC)
  • tamper-evident sealed packets
  • do not use any opened or torn packets