Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE SOFTGEL HEALTHCARE PVT LTD FDA Approved Uses temporarily relieves these symptoms due to cold/flu: minor aches and pains headache nasal and sinus congestion cough sore throat runny nose sneezing temporarily reduces fever
FunFoxMeds box
Substance Acetaminophen
Route
ORAL
Applications
M012

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each Capsule) Acetaminophen USP 325 mg Dextromethorphan Hydrobromide USP 10 mg Doxylamine Succinate USP 6.25 mg Phenylephrine Hydrochloride USP 5 mg
Inactive Ingredients
Inactive ingredients candurin silver sheen candurin silver sparkle D&C yellow no.10 FD&C blue no.1 gelatin glycerin polyethylene glycol 400 povidone K 30 purified water sorbitol sorbitan solution
Strengths
325 mg 10 mg 6.25 mg 5 mg
Treats Conditions
Uses Temporarily Relieves These Symptoms Due To Cold Flu Minor Aches And Pains Headache Nasal And Sinus Congestion Cough Sore Throat Runny Nose Sneezing Temporarily Reduces Fever
Pill Appearance
Shape: oval Color: green

Identifiers & Packaging

Container Type UNKNOWN
UNII
362O9ITL9D 9D2RTI9KYH V9BI9B5YI2 04JA59TNSJ
Packaging

bulk label

Package Descriptions
  • bulk label

Overview

Uses temporarily relieves these symptoms due to cold/flu: minor aches and pains headache nasal and sinus congestion cough sore throat runny nose sneezing temporarily reduces fever

Indications & Usage

Uses temporarily relieves these symptoms due to cold/flu: minor aches and pains headache nasal and sinus congestion cough sore throat runny nose sneezing temporarily reduces fever

Dosage & Administration

Directions do not take more than the recommended dose adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 4 capsules in 12 hours or as directed by a doctor. children under 12 years: do not use

Warnings & Precautions
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin 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.
Purpose

Purposes Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant

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 12 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 children

Stop Use & Ask a Doctor

Stop use and ask a doctor if 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 cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. nervousness, dizziness, or sleeplessness occurs

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 medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


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