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Drug Facts
Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224
Made in England
Childrens Mucinex
FDA Label NDC 63824-279
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rb Health (us) Llc for the product Childrens Mucinex (NDC 63824-279). 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, ask a doctor before use if the child has, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients (in each 5 mL) | Purpose |
|---|---|
| Dextromethorphan HBr 5 mg | Cough suppressant |
| Guaifenesin 100 mg | Expectorant |
| Phenylephrine HCl 2.5 mg | Nasal decongestant |
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help your child get to sleep
- nasal congestion due to a cold
- stuffy nose
Otc - Do Not Use
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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with asthma
When Using This Product
- do not use more than directed
Stop Use And Ask A Doctor If
- your child gets nervous, dizzy or sleepless
- symptoms do not get better within 7 days or occur with fever
- cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.
Otc - 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.
Directions
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided
- do not use dosing cup with other products
- dose as follows or as directed by a doctor
- mL = milliliter
| 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 |
Other Information
- each 5 mL contains: sodium 3 mg
- tamper evident: do not use if neckband on bottle cap is broken or missing
- store between 20-25°C (68-77°F)
- do not refrigerate
- dosing cup provided
Inactive Ingredients
anhydrous citric acid, D&C red #33, dextrose, FD&C blue #1, FD&C red #40, flavors, glycerin, methylparaben, potassium sorbate, propyl gallate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sorbitol, sucralose, xanthan gum
Questions?
1-866-MUCINEX (1-866-682-4639) You may also report side effects to this phone number.
Principal Display Panel - 201 Ml Bottle Carton
VALUE SIZE!
NDC 63824-279-67
Children's
Mucinex®
Congestion
& Cough
| Guaifenesin 100 mg | Expectorant |
| Dextromethorphan HBr 5 mg | Cough Suppressant |
| Phenylephrine HCl 2.5 mg | Nasal Decongestant |
✔ Chest Congestion✔ Breaks up Mucus✔ Stuff Nose✔ Cough
Berrylicious
Flavor Liquid
6.8 FL OZ
(201 mL)
Principal Display Panel (201 mL Bottle Carton)
* Please review the disclaimer below.
