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 Walgreens Company. 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.
Other
Drug Facts
Active Ingredient (In Each 5 Ml)
Guaifenesin, USP 100 mg
Purpose
Expectorant
Uses
▪ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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.
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▪ store at room temperature▪ do not refrigerate▪ dosing cup provided
Inactive Ingredients
anhydrous citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, natural and artificial flavors, potassium citrate propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.
Principal Display Panel - 120 Ml
NDC 0363-7504-04
Children's
Chest Congestion Relief
Guaifenesin
Oral Solution, USP
Expectorant
• Relieves Chest Congestion• Breaks up Mucus• Alcohol Free
GrapeFlavor
Naturally and Artificially Flavored
4 FL OZ(120 mL)
IMPORTANT: Keep this carton for future reference on full labeling. |
*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children’s Mucinex.® Chest Congestion
Distributed by:
WALGREEN CO.
200 WILTMOT RD. DEERFIELD, IL 60015
* Please review the disclaimer below.
