Alka Seltzer Cold Cold And Flu Severe Day Night Fast Dissolve Kit
FDA Label NDC 0280-8287

Alka-Seltzer Cold Cold & Flu Severe Day Fast Dissolve Effervescent Tablets

Drug Facts

Alka-Seltzer Cold Cold & Flu Severe Fast Dissolve Night Effervescent Tablets

Active ingredients (in each tablet)

Acetaminophen 250mg

Dextromethorphan hydrobromide 10 mg

Active ingredients (in each tablet)

Acetaminophen 250 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan hydrobromide 10 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Purposes

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Uses

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

 • minor aches and pains  • headache • sore throat

 • cough

 • temporarily reduces fever

Warnings

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

● more than 10 tablets in 24 hours, which is the maximum daily amount for this product

● with other drugs containing acetaminophen

● 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.

Warnings

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

● more than 10 tablets in 24 hours, which is the maximum daily amount for this product

● with other drugs containing acetaminophen

● 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 to sedate children.

Do not use

● with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contatins 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 12 years of age

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 12 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 before use if you have

● liver disease ● glaucoma

● cough that is accompanied by excessive phlegm (mucus)

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

or emphysema

● difficulty in urination due to enlargement of the prostate gland

● a sodium-restricted diet

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin

• taking sedatives or tranquilizers

Stop use and ask a doctor if

● pain or cough 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

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

Stop use and ask a doctor if

● pain or cough 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

● 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.

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.

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 fully dissolved in 4 oz of water every 4 hours. Do not exceed 10 tablets in 24 hours or as directed by a doctor.

● children under 12 years: do not use

Directions

● do not take more than the recommended dose

● adults and children 12 years and over: take 2 tablets fully dissolved

in 4 oz of water every 4 hours. Do not

exceed 10 tablets in 24 hours or as directed by a doctor.

● children under 12 years: do not use

Other information

● each tablet contains: potassium 80 mg; sodium 355 mg

● store between 20 ^oC to 25 ^oC (68 ^oF to 77 ^oF). Avoid excessive heat above 40 ^oC (104 ^o​F).

Other information

● each tablet contains: potassium 80 mg; sodium 355 mg

● store between 20 ^oC to 25 ^oC (68 ^oF to 77 ^oF). Avoid excessive heat above 40 ^oC (104 ^o​F).

Inactive ingredients anhydrous citric

acid, calcium silicate, dimethicone, flavors, magnesium stearate, maltodextrin, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose

Inactive ingredients anhydrous citric

acid, calcium silicate, dimethicone, flavors, magnesium stearate, maltodextrin, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose

Questions or comments? 1-800-986-0369 (Mon – Fri 8AM –

8PM EST)

Uses

 • temporarily relieves these symptoms due to a cold or flu:

 • minor aches and pains  • headache

 • cough  • sore throat  • runny nose  • sneezing

 • temporarily reduces fever

When using this product

● may cause marked drowsiness

● alcohol, sedatives, and tranquilizers may increase the drowsiness effect

● avoid alcoholic drinks

● be careful when driving a motor vehicle or operating machinery

● excitability may occur, especially in children

Questions or comments?1-800-986-0369 (Mon-

Fri 8AM – 8PM EST)