Alka Seltzer Cold Cold And Cough Fast Tablet, Chewable
FDA Label NDC 0280-8279

Drug Facts

Active ingredients (in each tablet) Purposes

Acetaminophen 162.5 mg…………….………...Pain reliever/fever reducer

Dextromethorphan hydrobromide 5 mg…….....………Cough suppressant

Uses

· temporarily relieves these symptoms due to a cold or flu:

· minor aches and pains · headache

· cough · sore throat

· temporarily reduces fever

Warnings

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

· adult takes more than 12 tablets in 24 hours. which is the maximum daily amount for this product

· child takes more than 5 doses in 24hours

· taken with other drugs containing acetaminophen

· adult has 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin or severe

allergic reactions. Symptoms may include:

· skin reddening · blisters · rash · hives

· facial swelling · asthma (wheezing) · shock

If a skin or general allergic 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.

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.

● if you have ever had an allergic reaction to this product or any of its ingredients

● in children under 6 years of age

Ask a doctor before use if you have

● liver disease

● cough that is accompanied by excessive phlegm (mucus)

● persistent or chronic cough such as occurs with smoking, asthma,

or emphysema

● a sodium restricted diet

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

Stop use and ask a doctor if

· pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)

· fever gets worse or lasts more than 3 days

· redness or swelling is present

· new symptoms occur

· cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

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

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

Directions

· do not take more than the recommended dose

· adults and children 12 years and over: take 2 tablets every 4 hours.

Do not exceed 6 doses (12 tablets) tablets in 24 hours or as directed by a

doctor.

· children 6 to under 12 years: take 2 tablets every 4 hours. Do not

exceed 5 doses (10 tablets) in 24 hours or as directed by a doctor.

· do not swallow tablets whole. Chew or crush tablets completely

before swallowing.

· children under 12 years: do not use

Other information

● each tablet contains: sodium 17 mg

● store at 20-25 ^oC (68-77 ^oF). Avoid excessive heat above 40 ^o C

(104 ^o F)

Inactive ingredients anhydrous citric acid, betadex,

carboxymethylcellulose, colloidal silicon dioxide, ethylcellulose, flavors,

magnesium stearate, mannitol, microcrystalline cellulose, polyethylene,

sodium bicarbonate, sodium starch glycolate, stearic

acid, sucralose, xylitol

Questions or comments? 1-800-986-0369 (Mon-Fri 8AM - 8PM EST)