alka-seltzer plus cough and sore throat fizzychews ui 1615059

alka-seltzer plus cough and sore throat fizzychews ui 1615059
SPL v2
SPL
SPL Set ID 14951faa-9476-6f29-e063-6394a90a14c7
Route
oral
Published
Effective Date 2024-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dextromethorphan (5 mg) acetaminophen (162.5 mg)
Inactive Ingredients
stearic acid magnesium stearate mannitol anhydrous citric acid sucralose sodium bicarbonate cellulose, microcrystalline silicon dioxide xylitol betadex sodium starch glycolate type a

Identifiers & Packaging

Pill Appearance
Imprint: ASP;13 Shape: round Color: white Size: 17 mm Score: 1
Marketing Status
otc monograph drug active Since 2024-04-01

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

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

· adult takes more than 4,000 mg of acetaminophen in 24 hours

· 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.

Active Ingredient

Active ingredients (in each tablet) Purposes

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

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

Indications and Usage

Uses

· temporarily relieves these symptoms due to a cold:

· minor aches and pains · headache

· cough · sore throat

· temporarily reduces fever

Directions

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

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9



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.

Section 50567-7

When using this product

● do not exceed recommended dosage

● may cause marked drowsiness

● avoid alcoholic drinks

● alcohol, sedatives, and tranquilizers may increase drowsiness

● be careful when driving a motor vehicle or operating machinery

● excitability may occur, especially in childre

Section 50568-5

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

Section 50569-3

Ask a doctor before use if you have

● liver disease

● cough with excessive phlegm (mucus)

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

or emphysema

● a sodium restricted diet

Section 50570-1

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

Section 51727-6

Inactive ingredients anhydrous citric acid, betadex,

carboxymethylcellulose, colloidal silicon dioxide, ethylcellulose, flavors,

magnesium stearate, mannitol, microcrystalline cellulose, polyethylene,

sodium bicarbonate, sodium carbonate, sodium starch glycolate, stearic

acid, sucralose, xylitol

Section 51945-4

Alka-Seltzer® PLUS

Cough & Sore Throat FIZZY CHEWS

ACETAMINOPHEN/Pain Reliever-Fever Reducer

Dextromethorphan HBr/ Cough Supressant

  • Fever & Body Ache
  • Cough
  • Sore Throat

ACTIVATES WITHOUT WATER

24 CHEWABLE TABLETS

Section 53414-9

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

Section 60561-8

Other information

each tablet contains: sodium 17 mg

● store at room temperature. Avoid excessive heat above 40 o C

(104 o F)

Questions Or Comments

Questions or comments? 1-800-986-0369 (Mon-Fri 9AM - 5PM EST)


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

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

· adult takes more than 4,000 mg of acetaminophen in 24 hours

· 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.

Active Ingredient (55106-9)

Active ingredients (in each tablet) Purposes

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

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

Indications and Usage (34067-9)

Uses

· temporarily relieves these symptoms due to a cold:

· minor aches and pains · headache

· cough · sore throat

· temporarily reduces fever

Directions

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)



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.

Section 50567-7 (50567-7)

When using this product

● do not exceed recommended dosage

● may cause marked drowsiness

● avoid alcoholic drinks

● alcohol, sedatives, and tranquilizers may increase drowsiness

● be careful when driving a motor vehicle or operating machinery

● excitability may occur, especially in childre

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

Ask a doctor before use if you have

● liver disease

● cough with excessive phlegm (mucus)

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

or emphysema

● a sodium restricted diet

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Inactive ingredients anhydrous citric acid, betadex,

carboxymethylcellulose, colloidal silicon dioxide, ethylcellulose, flavors,

magnesium stearate, mannitol, microcrystalline cellulose, polyethylene,

sodium bicarbonate, sodium carbonate, sodium starch glycolate, stearic

acid, sucralose, xylitol

Section 51945-4 (51945-4)

Alka-Seltzer® PLUS

Cough & Sore Throat FIZZY CHEWS

ACETAMINOPHEN/Pain Reliever-Fever Reducer

Dextromethorphan HBr/ Cough Supressant

  • Fever & Body Ache
  • Cough
  • Sore Throat

ACTIVATES WITHOUT WATER

24 CHEWABLE TABLETS

Section 53414-9 (53414-9)

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

Section 60561-8 (60561-8)

Other information

each tablet contains: sodium 17 mg

● store at room temperature. Avoid excessive heat above 40 o C

(104 o F)

Questions Or Comments (Questions or comments)

Questions or comments? 1-800-986-0369 (Mon-Fri 9AM - 5PM EST)


Advanced Ingredient Data


Raw Label Data

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