Acetaminophen and Guaifenesin

FDA Drug Profile — Mucinex Childrens Mini Melts Cold and Flu, Mucinex Sinus Max Clear and Cool

Acetaminophen and Guaifenesin is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand names including Mucinex Childrens Mini Melts Cold and Flu, Mucinex Sinus Max Clear and Cool. Available dosage forms: granule, capsule, liquid filled.

Drug Details

Generic Name
Acetaminophen and Guaifenesin
Brand Names
Mucinex Childrens Mini Melts Cold and Flu, Mucinex Sinus Max Clear and Cool
Application Number
M012
Sponsor
Reckitt Benckiser LLC
NDC Codes
2
Dosage Forms
GRANULE, CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients
ACETAMINOPHEN, GUAIFENESIN

Indications and Usage

Uses Temporarily relieves minor aches and pains due to: ■ the common cold ■ flu ■ headache ■ sore throat ■ temporarily reduces fever ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

Warnings Liver warning : This product contains acetaminophen. Severe liver damage may occur if ■ adult takes more than 6 doses (24 packets) in 24 hours, which is the maximum daily amount ■ child takes more than 5 doses (10 packets) 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 ■ blister ■ 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 with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have Ask a doctor before use if the user has ■ liver disease ■ persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema ■ cough accompanied by too much phlegm (mucus) Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin When using this product do not use more than directed 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. 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.