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SanaTos Severe Cold and Cough Nighttime


SPL UNCLASSIFIED SECTION

Drug Facts


OTC - PURPOSE SECTION

Acetaminophen 650 mgPain reliever/ fever reducer
Diphenhydramine HCI 25 mgAntihistamine/ cough suppressant
Phenylephrine HCI 10 mgNasal decongestant

Uses

Temporarily relieves common cold/flu symptoms:

  • headache
  • sore throat
  • minor aches & pains
  • nasal congestion & itchy, watery eyes due to hay fever
  • other respiratory allergies
  • cough due to minor throat & bronchial irritation
  • itchy nose and throat
  • runny nose
  • sneezing
  • stuffy nose
  • and reduces fever

Warnings

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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

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

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

  • more than 6 doses 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

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 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.
  • for more than 7 days for pain and 3 days for fever, unless directed by a doctor
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • a breathing problem such as emphysema
  • chronic bronchitis
  • trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

  • may cause excitability especially in children
  • may cause marked drowsiness; 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

Stop use and ask doctor if

  • new symptoms occur
  • pain or fever persists or gets worse
  • symptoms do not improve within 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
  • if nervousness, dizziness, or sleeplessness occur

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

  • do not exceed recommended dosage
  • take every 4 hours; do not take more than 6 packets in 24- hour period
  • dissolve contents of one packet into 8 oz. hot water and sip while hot; consume entire drink within 10-15 minutes
  • if using a microwave; add contents of one packet to 8 oz. of cool water, stir briskly before and after heating. Do not overheat.

DOSAGE & ADMINISTRATION SECTION

Age Dose
adults & children 12 years of age & overone packet every 4 hours
children under 12 years of agedo not use

Other information

TAMPER EVIDENT: Do not use if packets are broken or torn.

  • each packet contains: potassium 10 mg, sodium 27 mg
  • phenylketonurics: contains phenylalanine 13 mg per packet
  • store at room temperature 68-77°F (20-25°C)
  • protect from excessive heat and moisture

Inactive ingredients

acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow 10, FD&C blue 1, FD&C red 40, flavors, isopropyl alcohol, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate, water


SPL UNCLASSIFIED SECTION

Distributed by:

PHARMADEL

Georgetown, DE 19947

Made in India