Active Ingredients (In Each 5 Ml)
Dextromethorphan HBr 5 mg
Guaifenesin 100 mg
Childrens Mucus Relief Cough Liquid
FDA Label NDC 76162-294
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates for the product Childrens Mucus Relief Cough (NDC 76162-294). 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 active ingredients (in each 5 ml), purposes, uses, do not use, ask a doctor before use if the child has, stop use and ask a doctor if, 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
Purposes
Cough suppressant
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
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 taking this product.
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
Stop Use And Ask A Doctor If
cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device.
- keep dosing cup with product
- mL = milliliter
- shake well before using
| age | dose |
| children 6 to under 12 years | 5-10 mL every 4 hours |
| children 4 to 5 years | 2.5-5 mL every 4 hours |
| children under 4 years | do not use |
Other Information
- each 5 mL contains: sodium 2 mg
- store between 20-25°C (68-77°). Do not refrigerate.
Inactive Ingredients
citric acid, D&C red #33, dextrose, FD&C red #40, flavor, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sucralose, xanthan gum
Questions Or Comments?
Call toll free 1-888-423-0139
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Compare to Children's Mucinex® Cough active ingredients*
Children's Cough Mucus Relief
Dextromethorphan HBr 5 mg - Cough Suppressant
Guaifenesin 100 mg - Expectorant
Relieves:
- cough
- chest congestion
- breaks up mucus
Alcohol Free
For Ages 4 to 11 Years
Cherry Flavor
FL OZ (mL)
Dosing Cup Included
*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children's Mucinex® Cough.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
Distributed by TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
[email protected] www.topcarebrand.com
Package Label
Topcare Children's Mucus Relief Cough Cherry Liquid
* Please review the disclaimer below.
