Drug Facts
Composition & Profile
Identifiers & 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
- 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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