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
  • AgeDose
    children 6 years to under 12 years5 mL to 10 mL or 1-2 teaspoonfuls every 4 hours
    childen 4 years to under 6 years2.5 mL to 5 mL or 1/2-1 teaspoonful every 4 hours
    children under 4 yearsdo 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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