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Drug Facts
Childrens Mucus And Cough Relief Liquid
FDA Label NDC 63868-771
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Manufacturing Assn for the product Childrens Mucus And Cough Relief (NDC 63868-771). 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 - stop use, otc - keep out of reach of children, directions, 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) | Purposes |
Dextromethorphan HBr 5 mg | Cough suppressant |
Guaifenesin 100 mg | Expectorant |
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
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.
Otc - Ask Doctor
Ask a doctor before use if the child has
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with asthma
Otc - Stop Use
Stop use and ask a doctor if 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 at 1-800-222-1222.
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
- mL = milliliter
| Age | Dose |
|---|---|
children 6 years to under 12 years | 5 mL – 10 mL every 4 hours |
children 4 years to under 6 years | 2.5 mL – 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 printed inner seal under cap is torn or missing
- store at room temperature
- do not refrigerate
- dosing cup provided
Inactive Ingredients
Anhydrous citric acid, edetate disodium, FD&C Red#40, flavors, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
Principal Display Panel - 118 Ml Bottle Carton
NDC 63868-771-04
Compare to the Active ingredient in Children’s Mucinex Cough*
Children's
Mucus &Cough Relief
Cough Suppressant
Expectorant
Dextromethorphan HBr
Guaifenesin
Each Dose of Cherry Flavored
Children's
Mucus & Cough Relief:
Controls Cough
Relieves Chest Congestion
Breaks up Mucus
Alcohol-free
See New Dosing information
Cherry
Flavor
4 FL OZ
(118 mL)
IMPORTANT: Keep this carton for future reference on full labeling. |
DOSAGE CUP INCLUDED
Distributed by C.D.M.A., Inc©
43157 W. Nine Mile
Novi, MI 48376-0995
Questions: 248-449-9300
*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children’s Mucinex.®
QC 100% Satisfaction Guaranteed.
Quality Choice Children's Mucus And Cough Relief Cherry Flavor 4 Fl Oz (Mucinex 01)
* Please review the disclaimer below.
