Other
Drug Facts
Dist. By: RB Health (US)
Parsippany, NJ 07054-0224
Made in Germany
The following Structured Product Label (SPL) was submitted to the FDA by Reckitt Benckiser Llc for the product Mucinex Childrens (NDC 72854-090). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, uses, warnings, otc - do not use, ask a doctor before use if you have, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Dist. By: RB Health (US)
Parsippany, NJ 07054-0224
Made in Germany
Active ingredients (in each packet)
Acetaminophen 162.5 mg
Guaifenesin 100 mg
| Active ingredients (in each packet) | Purposes |
|---|---|
| Acetaminophen 162.5 mg | Fever Reducer/Pain Reliever |
| Guaifenesin 100 mg | Expectorant |
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
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 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.
| Age | Dose |
|---|---|
| adults and Children 12 years of age and over | 2 to 4 packets every 4 hours, not to exceed 6 doses (24 packets) in 24 hours |
| children 6 years to under 12 years of age | 2 packets every 4 hours, not to exceed 5 doses (10 packets) in 24 hours |
| children under 6 years of age | do not use |
amino methacrylate copolymer,
carbomer homopolymer type A,
carboxymethylcellulose sodium,
hypromellose, magnesium
stearate, microcrystalline
cellulose, povidone, colloidal
silicon dioxide, simethicone,
sodium bicarbonate, sorbitol,
sodium lauryl sulphate, sucralose,
stearic acid, strawberry flavor,
talc, triethyl citrate, vanilla flavor
1-866-682-4639
You may also report side effects to this phone number.
Pediatrician Recommended*
NDC 72854-090
* Please review the disclaimer below.