Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE SOFTGEL HEALTHCARE PRIVATE LIMITED FDA Approved Uses • temporarily relieves these symptoms due to a cold or flu : • minor aches and pains • headache • cough • sore throat • nasal and sinus congestion • temporarily reduces fever
FunFoxMeds box
Substance Acetaminophen
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredients (in each capsule) Acetaminophen USP 325 mg Dextromethorphan HBr USP 10 mg Doxylamine Succinate USP 6.25 mg
Inactive Ingredients
Inactive ingredients D&C yellow no.10 FD&C blue no.1 gelatin glycerin mica polyethylene glycol 400 povidone K 30 purified water sorbitol sorbitan solution titanium dioxide
Strengths
325 mg 10 mg 6.25 mg
Treats Conditions
Uses Temporarily Relieves These Symptoms Due To A Cold Or Flu Minor Aches And Pains Headache Cough Sore Throat Nasal And Sinus Congestion Temporarily Reduces Fever
Pill Appearance
Shape: oval Color: green

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
362O9ITL9D 9D2RTI9KYH V9BI9B5YI2
Packaging

Bulk package Label label

Package Descriptions
  • Bulk package Label label

Overview

Uses • temporarily relieves these symptoms due to a cold or flu : • minor aches and pains • headache • cough • sore throat • nasal and sinus congestion • temporarily reduces fever

Indications & Usage

Uses • temporarily relieves these symptoms due to a cold or flu : • minor aches and pains • headache • cough • sore throat • nasal and sinus congestion • 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 10 capsules in 24 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 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.
Purpose

Purposes Pain reliever/fever reducer Cough suppressant Antihistamine

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

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


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