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Drug Facts
Drug Facts
Dist. by: RB Health (US)
Parsippany, NJ 07054-0224
Made in Mexico
The following Structured Product Label (SPL) was submitted to the FDA by Reckitt Benckiser Llc for the product Mucinex Childrens (NDC 63824-950). 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
Drug Facts
Dist. by: RB Health (US)
Parsippany, NJ 07054-0224
Made in Mexico
| Active ingredients (in each 10 mL) | Purposes |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Diphenhydramine HCl 12.5 mg | Antihistamine/cough suppressant |
| Phenylephrine HCl 5 mg | Nasal decongestant |
| Active ingredients (in each 5 mL) | Purposes |
|---|---|
| Dextromethorphan HBr 5 mg | Cough suppressant |
| Guaifenesin 100 mg | Expectorant |
| Phenylephrine HCl 2.5 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.
Keep out of reach of children.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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.
| Age | Dose |
|---|---|
| children 6 to under 12 years of age | 10 mL every 4 hours |
| children 4 to under 6 years of age | 5 mL every 4 hours |
| children under 4 years of age | do not use |
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 gumanhydrous citric acid, edetate disodium, 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 gum1-866-682-4639
You may also report side effects to this phone number.
1-866-MUCINEX (1-866-682-4639)
You may also report side effects to this phone number.
Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
When using this product do not use more than directed
Pediatrician Recommended†
TRIPLE
PACK
NDC 63824-944-34
READ ALL INFORMATION
Mucinex®
Children's
DAY TIME
MULTI-SYMPTOM
COLD
Dextromethorphan HBr 5 mg - Cough Suppressant
Guaifenesin 100 mg - Expectorant
Phenylephrine HCl 2.5 mg - Nasal Decongestant
Ages
4+ yrs
Very Berry
Flavor Liquid
THREE – 4 FL OZ (118mL)
NIGHT TIME
MULTI-SYMPTOM
COLD
Acetaminophen 325 mg–Pain Reliever/Fever Reducer
Diphenhydramine HCl 12.5–Antihistamine/
Cough Suppressant
Phenylephrine HCl mg–Nasal Decongestant
Ages
6+ yrs
Very Berry
Flavor Liquid
TOTAL – 12 FL OZ (354mL)
* Please review the disclaimer below.