Otc - Active Ingredient
DRUG FACTS
Active ingredients
(in each 5 mL teaspoonful)
Dextromethorphan HBr, USP 5 mg
Guaifenesin, USP 100 mg
Childrens Mucus Relief Cough - Cherry Flavor Liquid
FDA Label NDC 76281-512
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aptapharma Inc. for the product Childrens Mucus Relief Cough - Cherry Flavor (NDC 76281-512). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Dextromelhorphan HBr, USP ....... Cough Suppressant
Guaifenestn,USP ........................Expectorant
Indications & Usage
Uses
• temporarily relieves:cough due to minor throat and bronchial irritation as may occur with a cold
• helps loosen phlegm (mucus) and thin bronchial secretions to drain the bronchial tube
Warnings
Warnings
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
• 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
• cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.
These could be signs of a serious condition.
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.
Dosage & Administration
Directions
• do not take more than 6 doses in any 24-hour period
Age Dose
| Children 6 years to Under 12 years | 1 to 2 teaspoonfuls (tsps) every 4 hours |
| Children 4 years to Under 6 years | 1/2 to 1 teaspoonful (tsp) every 4 hours |
| Children under 4 years | do not use |
Other Safety Information
Other information • each teaspoon contains: sodium 3 mg
• store between 20-25°C (68-77°F) • do not refrigerate
• dosing cup provided • Keep carton for full direction for use
Inactive Ingredient
Inactive ingredients:anhydrous citric acid, dextrose, D&C red
#33, FD&C red #40, flavors, glycerin, maltitol, propylene glycol,
purified water, saccharin sodium, sodium benzoate, sucralose,
xanthan gum
Otc - Questions
Questions? Call weekdays from 9:30AM to 4:30 PM EST 1-877-798-5944
Children's Mucus Relief Cough Cherry
AP SAFE NDC 76281-512-24
Children's
Cough
Mucus Relief
Cough Suppressant
Expectorant
Cherry Flavor
4 FL OZ (118 mL)
DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING
*This product is not manufactured or distributed by
Reckitt Benckiser Inc., distributor of Children's
Mucinex®Cough.
Manufactured by:
AptaPharma Inc.,
1533 Union Ave.
Pennsauken, NJ 08110
res
* Please review the disclaimer below.
