Mucinex Childrens Mighty Chews Night Time Cold and Flu ACETAMINOPHEN DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE RB HEALTH (US) LLC FDA Approved Uses ■ temporarily relieves these common cold and flu symptoms: ■ minor aches and pains ■ sore throat ■ headache ■ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants ■ runny nose ■ sneezing ■ temporarily reduces fever ■ controls cough to help the user get to sleep
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Substance Acetaminophen
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Acetaminophen 162.5 mg Dextromethorphan HBr 5 mg Doxylamine succinate 3.125 mg
Inactive Ingredients
Inactive ingredients anhydrous citric acid corn syrup ethylcellulose FD&C blue no. 1 FD&C red no. 40 flavor glycerin malic acid maltodextrin pectin potassium sodium tartrate purified water sodium chloride sodium polymetaphosphate sucralose sucrose trisodium citrate (anhydrous)
Strengths
162.5 mg 5 mg 3.125 mg
Treats Conditions
Uses Temporarily Relieves These Common Cold And Flu Symptoms Minor Aches And Pains Sore Throat Headache Cough Due To Minor Throat And Bronchial Irritation As May Occur With The Common Cold Or Inhaled Irritants Runny Nose Sneezing Temporarily Reduces Fever Controls Cough To Help The User Get To Sleep
Pill Appearance
Shape: round Color: purple Imprint: M

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0363824999623
UNII
362O9ITL9D 9D2RTI9KYH V9BI9B5YI2
Packaging

NDC 72854-085-16 Children's Mucinex® Cough Suppressant Antihistamine Acetaminophen 162.5 mg Dextromethorphan HBr 5 mg Doxylamine succinate 3.125 m Age 6+ Mixed Berry Flavor Label

Package Descriptions
  • NDC 72854-085-16 Children's Mucinex® Cough Suppressant Antihistamine Acetaminophen 162.5 mg Dextromethorphan HBr 5 mg Doxylamine succinate 3.125 m Age 6+ Mixed Berry Flavor Label

Overview

Uses ■ temporarily relieves these common cold and flu symptoms: ■ minor aches and pains ■ sore throat ■ headache ■ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants ■ runny nose ■ sneezing ■ temporarily reduces fever ■ controls cough to help the user get to sleep

Indications & Usage

Uses ■ temporarily relieves these common cold and flu symptoms: ■ minor aches and pains ■ sore throat ■ headache ■ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants ■ runny nose ■ sneezing ■ temporarily reduces fever ■ controls cough to help the user get to sleep

Dosage & Administration

Directions ■ do not take more than directed (see Overdose warning) ■ chew thoroughly before swallowing ■ dose every 4 hours or as directed by a doctor adults and children 12 years of age and over 4 chewable tablets every 4 hours, not to exceed 6 doses (24 chewable tablets) in any 24-hour period children 6 to under 12 years of age 2 chewable tablets every 4 hours, not to exceed 5 doses (10 chewable tablets) in any 24-hour period children under 6 years of age do not use

Warnings & Precautions
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if: ■ adult takes more than 6 doses (24 chewable tablets) in 24 hours, which is the maximum daily amount ■ child takes more than 5 doses (10 chewable tablets) in 24 hours, which is the maximum daily amount ■ 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 reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash If a skin 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 make a child sleepy ■ 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 the user is 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. Ask a doctor before use if you have ■ has liver disease ■ has a sodium-restricted diet ■ has glaucoma ■ has a breathing problem such as emphysema or chronic bronchitis ■ has difficulty in urination due to enlargement of the prostate gland ■ is a child with pain of arthritis Ask a doctor or pharmacist before use if you are ■ taking the blood thinning drug warfarin ■ taking sedatives or tranquilizers When using this product ■ do not use more than directed (see Overdose warning) ■ excitability may occur, especially in children ■ marked drowsiness may occur ■ alcohol, sedatives, and tranquilizers may increase the drowsiness effect ■ avoid alcoholic beverages ■ use caution when driving a motor vehicle or operating machinery 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. These could be signs of a serious condition.
Purpose

Acetaminophen 162.5 mg................................................Pain reliever/fever reducer Dextromethorphan HBr 5 mg.......................... ...............Cough suppressant Doxylamine succinate 3.125 mg.................................................Antihistamine

Keep Out of Reach of Children

If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Questions

Questions? 1-866-MUCINEX (1-866-682-4639)


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