FDA Label for Childrens Chest Congestion Relief
View Indications, Usage & Precautions
Childrens Chest Congestion Relief Product Label
The following document was submitted to the FDA by the labeler of this product Chain Drug Consortium, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Drug Facts
Active ingredient (in each 5 mL teaspoonful)
Guaifenesin, USP 100 mg
Purpose
Expectorant
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.
Uses
- Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes coughs more productive.
Warnings
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 persistent headache.
- These could be signs of a serious condition.
Directions
- do not take more than 6 doses in any 24-hour period
Other Information
- each 5 mL teaspoon contains: sodium 3 mg
- store between 20-25 ° C (68-77° F)
- do not refrigerate
- dosage cup provided
- Keep carton for full directions for use
Inactive Ingredients
citric acid anhydrous, dextrose, FD and C Blue # 1, FD and C Red # 40, flavors, glycerin, maltitol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sucralose, xanthan gum
Questions?
Call weekdays from 9:30 AM to 4:30 PM EST
1-877-798-5944
Product Label
NDC 68016-157-04
*COMPARE TO THE ACTIVE INGREDIENTS IN CHILDRENS MUCINEX® CHEST CONGESTION
Premier Value®
Childrens Chest Congestion Relief
Guaifenesin Oral Solution, USP
EXPECTORANT
Relieves Chest Congestion
Thins and Loosens Mucus
Alcohol-Free
For Ages 4 to 12
Grape Flavor
4 FL OZ (118mL)
INDEPENDENTLY TESTED SATISFACTION GUARANTEED PV
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 Childrens Mucinex®
If for Any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.
DISTRIBUTED BY
CHAIN DRUG CONSORTIUM
3301 NW BOCA RATON BLVD
SUITE 101, BOCA RATON, FL 33431
BX-011
* Please review the disclaimer below.