CHEST CONGESTION- guaifenesin liquid

Chest Congestion by

Drug Labeling and Warnings

Chest Congestion by is a Otc medication manufactured, distributed, or labeled by Accudial Pharmaceutical, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

CHEST CONGESTION

Drug Facts

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

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 illness.

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
• 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

INGREDIENTS AND APPEARANCE

CHEST CONGESTION 
guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45014-150
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
Caramel (UNII: T9D99G2B1R)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Corn Syrup (UNII: 9G5L16BK6N)
FD&C RED NO. 40 (UNII: WZB9127XOA)
Glycerin (UNII: PDC6A3C0OX)
Menthol (UNII: L7T10EIP3A)
Propylene Glycol (UNII: 6DC9Q167V3)
Water (UNII: 059QF0KO0R)
Sodium Benzoate (UNII: OJ245FE5EU)
Saccharin Sodium (UNII: SB8ZUX40TY)

Product Characteristics
Color	RED (Reddish-Pink) , PINK	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45014-150-04	118 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	10/26/2009

Labeler - Accudial Pharmaceutical, Inc. (831999201)