FDA Label for Chest Congestion
View Indications, Usage & Precautions
Chest Congestion Product Label
The following document was submitted to the FDA by the labeler of this product Accudial Pharmaceutical, Inc.. 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 (In Each 5 Ml Tsp)
Guaifenesin 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
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
Directions
- do not take more than 6 doses in any 24-hour period
- to find right dose, use rotating bottle label to dose by weight; otherwise, use chart at right to dose by age
- specifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product.
Do not use any other device
Age | Dose |
---|---|
children 6 years to under 12 years | 5 mL to 10 mL or 1-2 teaspoonfuls every 4 hours |
childen 4 years to under 6 years | 2.5 mL to 5 mL or 1/2-1 teaspoonful every 4 hours |
children under 4 years | do not use |
Other Information
- tamper evident: do not use if foil seal under bottle cap is broken or missing.
- store between 20°-25°C (68°-77°F)
Inactive Ingredients
caramel powder, citric acid, corn syrup, FD&C red no. 40, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium saccharin.
Questions?
877-434-2036
Principal Display Panel - 118 Ml Carton
CHILDREN'S
ACCUDIAL
ROTATING DOSING LABEL
ACCURATE DOSING
BY WEIGHT
Guaifenesin
Oral Solution
Expectorant
RELIEVES
Chest Congestion
Thins & Loosens
Mucus
For Ages 4 to under 12
Alcohol Free
Compares to
Mucinex® For Kids!
MENTHOL
FLAVOR
4 FL. OZ.
(118 mL)
NDC 45014-150-04
Chest Congestion
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