Other
Day Time Multi-Symptom Cold – Age 4+
Drug Facts
Night Time Multi-Symptom Cold – Age 6+
Drug Facts
Dist. by: Reckitt Benckiser, Parsippany, NJ 07054-0224
Made in England
The following Structured Product Label (SPL) was submitted to the FDA by Reckitt Benckiser Llc for the product Childrens Mucinex Multi Symptom Cold And Childrens Mucinex Night Time Multi Symptom Cold (NDC 63824-287). 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, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Day Time Multi-Symptom Cold – Age 4+
Drug Facts
Night Time Multi-Symptom Cold – Age 6+
Drug Facts
Dist. by: Reckitt Benckiser, Parsippany, NJ 07054-0224
Made in England
| Active ingredients (in each 5 mL) | Purposes |
|---|---|
| Dextromethorphan HBr 5 mg | Cough suppressant |
| Guaifenesin 100 mg | Expectorant |
| Phenylephrine HCl 2.5 mg | Nasal decongestant |
| 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 |
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.
Ask a doctor before use if the child has
When using this product do not use more than directed
Stop use and ask a doctor if
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Keep out of reach of children.
| Age | Dose |
|---|---|
| children 6 years to under 12 years | 10 mL every 4 hours |
| children 4 years to under 6 years | 5 mL every 4 hours |
| children under 4 years | do not use |
anhydrous citric acid, edetate disodium, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate
may contain this ingredient
, xanthan gumanhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, 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.
1-866-MUCINEX (1-866-682-4639)
You may also report side effects to this phone number.
This product contains acetaminophen. Severe liver damage may occur if your child takes:
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.
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 for adults as well as for children even if you do not notice any signs or symptoms.
VALUE
PACK
NDC 63824-287-22
Children's
Mucinex®
DAY TIME
Multi-Symptom
Cold
Cough Suppressant
Expectorant
Nasal Decongestant
Dextromethorphan HBr 5 mg
Guaifenesin 100 mg
Phenylephrine HCl 2.5 mg
✓ Stuffy Nose
✓ Cough
✓ Chest Congestion
✓ Breaks up Mucus
Age 4+
Very Berry
Flavor Liquid
4 FL OZ (118 mL)
NIGHT TIME
Multi-Symptom
Cold
Pain Reliever/Fever Reducer
Antihistamine/Cough Suppressant
Nasal Decongestant
Acetaminophen 325 mg
Diphenhydramine HCl 12.5 mg
Phenylephrine HCl 5 mg
✓ Stuffy Nose
✓ Cough
✓ Runny Nose & Sneezing
✓ Fever & Sore Throat
Age 6+
Mixed Berry
Flavor Liquid
4 FL OZ (118 mL)
8 FL OZ (236 mL) TOTAL
* Please review the disclaimer below.