Alka-Seltzer Plus Severe Cold & Cough PowerFast Fizz Effervescent Tablets UI 1614459
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each tablet) Purposes
Aspirin 325 mg (NSAID)*….……..…………...Pain reliever/fever reducer
Chlorpheniramine maleate 2 mg……………..…………...…Antihistamine
Dextromethorphan hydrobromide 10 mg………….…Cough suppressant
Phenylephrine bitartrate 7.8 mg.......…………….…..Nasal decongestant
*nonsteroidal anti-inflammatory drug
Uses
Uses
· temporarily relieves these symptoms due to a cold with cough:
· minor aches and pains · headache · cough
· runny nose · nasal and sinus congestion
· sneezing · sore throat
· temporarily reduces fever
WARNINGS SECTION
Warnings
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: Aspirin may cause a severe allergic reaction which may include:
· hives · facial swelling · asthma (wheezing) · shock
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
● 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
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.
Do not use to sedate children.
OTC - DO NOT USE SECTION
Do not use
● if you are allergic to aspirin or any other pain reliever/fever reducer
● 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.
● if you have ever had an allergic reaction to this product or any of its
ingredients
● in children under 12 years of age
OTC - ASK DOCTOR SECTION
Ask a doctor before use if
● 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,
or kidney disease
● you are taking a diuretic
● you have
● asthma ● diabetes ● thyroid disease ● glaucoma
● cough with excessive phlegm (mucus)
● a breathing problem such as emphysema or chronic bronchitis
● difficulty in urination due to enlargement of the prostate gland
● persistent or chronic cough such as occurs with smoking, asthma,
or emphysema
● a sodium-restricted diet
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
taking a prescription drug for
· gout · diabetes · arthritis
● taking sedatives or tranquilizers
When using
When using this product
● do not exceed recommended dosage
· may cause marked drowsiness
● avoid alcoholic drinks
● excitability may occur, especially in children
● alcohol, sedatives, and tranquilizers may increase drowsiness
● be careful when driving a motor vehicle or operating machinery
Stop use
Stop use and ask a doctor if
· an allergic reaction occurs. Seek medical help right away.
● 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
· pain, cough, or nasal congestion gets worse or lasts more than 7 days
· fever gets worse or lasts more than 3 days
· redness or swelling is present
· new symptoms occur
· ringing in the ears or a loss of hearing occurs
· cough comes back or occurs with rash or headache that lasts. These
could be signs of a serious condition.
· nervousness, dizziness, or sleeplessness occurs
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely 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
Directions
● adults and children 12 years and over: take 2 tablets fully dissolved
in 4 oz of water every 4 hours. Do not exceed 8 tablets in 24 hours
or as directed by a doctor.
● children under 12 years: do not use
OTHER SAFETY INFORMATION
Other information ● each tablet contains: potassium 80 mg; sodium 356 mg
● store at room temperature. Avoid excessive heat.
INACTIVE INGREDIENT SECTION
anhydrous citric acid, calcium silicate, dimethicone, flavor, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose
Carton 24 count
Alka-Seltzer®
PLUS
SEVERE
Cold &
Cough
Citrus
POWERFAST FIZZ™
NEW IMPROVED FLAVOR
ASPIRIN (NSAID) / Pain Reliever Reducer
Chlorpheniramine Maleate / Antihistamine
Dextromethorphan HBr / Cough Suppressant
Phenyleprine Bitartrate / Nasal Decongestant
24 EFFERVESCENT TABLETS