Other
Drug Facts
Dist. by: RB Health (US)
Parsippany, NJ 07054-0224
©2019 RB Health
Made in Mexico
The following Structured Product Label (SPL) was submitted to the FDA by Reckitt Benckiser Llc for the product Mucinex Childrens (NDC 63824-954). 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 - purpose, uses, liver warning, allergy alert, sore throat warning, do not use, ask a doctor before use if the child has, 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
©2019 RB Health
Made in Mexico
| Active ingredients (in each 10 mL) | Purposes |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 10 mg | Cough suppressant |
| Guaifenesin 200 mg | Expectorant |
| Phenylephrine HCl 5 mg | Nasal decongestant |
This product contains acetaminophen. Severe liver damage may occur if your child takes:
Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
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.
Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin
When using this product do not use more than directed (see Overdose warning)
Keep out of reach of children.
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. Quick medical attention is critical even if you do not notice any signs or symptoms.
anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin (soy), propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate
may contain this ingredient
, xanthan gum1-866-MUCINEX (1-866-682-4639) You may also report side effects to this phone number.
Pediatrician Recommended†
NDC 63824-954-04
Mucinex®
Children's
COLD & FLU
Acetaminophen 325 mg – Pain Reliever/Fever Reducer
Dextromethorphan HBr 10 mg – Cough Suppressant
Guaifenesin 200 mg – Expectorant
Phenylephrine HCl 5 mg – Nasal Decongestant
HEADACHE
SORE THROAT
CHEST CONGESTION
SINUS PRESSURE
SINUS CONGESTION
BODY PAIN
FEVER
COUGH
NASAL CONGESTION
ALL IN
ONE*
Ages
6+
yrs
Very Berry
Flavor Liquid
4 FL OZ (118 mL)
* Please review the disclaimer below.