Alka-Seltzer Plus Cough and Sore Throat FizzyChews ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE BAYER HEALTHCARE LLC. FDA Approved Uses · temporarily relieves these symptoms due to a cold: · minor aches and pains · headache · cough · sore throat · temporarily reduces fever
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Substance Acetaminophen
Route
ORAL
Applications
M012

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each tablet) Purposes Acetaminophen 162.5 mg…………….………...Pain reliever/fever reducer Dextromethorphan hydrobromide 5 mg…….....………Cough suppressant
Inactive Ingredients
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
Strengths
162.5 mg 5 mg
Treats Conditions
Uses Temporarily Relieves These Symptoms Due To A Cold Minor Aches And Pains Headache Cough Sore Throat Temporarily Reduces Fever
Pill Appearance
Shape: round Color: white Imprint: ASP;13

Identifiers & Packaging

Container Type UNKNOWN
UPC
0016500601715
UNII
362O9ITL9D 9D2RTI9KYH
Packaging

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 ASP Fizzy Chews PDP

Package Descriptions
  • 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 ASP Fizzy Chews PDP

Overview

Uses · temporarily relieves these symptoms due to a cold: · minor aches and pains · headache · cough · sore throat · temporarily reduces fever

Indications & Usage

Uses · temporarily relieves these symptoms due to a cold: · minor aches and pains · headache · cough · sore throat · temporarily reduces fever

Dosage & Administration

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

Warnings & 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. 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 with 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 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 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. 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
Do Not Use

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

When Using

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

Stop Use & Ask a Doctor

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.

Keep Out of Reach of Children

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

Questions

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


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