CHEST CONGESTION- guaifenesin solution
Bio-Pharm, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Chest Congestion

Drug Facts

Active ingredient (in each 5 mL TSP (teaspoon))

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.

Warnings

Ask a doctor before use if the child has a cough that occurs with too much phlegm (mucus) or 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. (1-800-222-1222). Prompt medical attention is critical, even if you do not notice any signs or symptoms.

Directions

Do not use more than 6 doses in any 24 hour period

May be given every 4 hours
Use only enclosed dosing cup to dose this product.
TSP = teaspoon

Age (yr)	Dose (TSP)
under 4 years	do not use
4 years to under 6 years	1/2 TSP to 1 TSP
6 years to under 12 years	1 TSP to 2 TSP
or as directed by a doctor

Other information

each TSP (5 mL) contains: sodium 3 mg
store at 20°-25°C (68°-77°F)
TAMPER-EVIDENT: Do not use if foil seal over mouth of the bottle is torn, broken, or missing.
do not refrigerate

Inactive ingredients

artificial grape flavor, citric acid, corn syrup, FD&C blue #1, D&C red #33, glycerin, purified water, sodium benzoate, sodium saccharin, sucralose, xanthan gum

Questions or comments

866-845-1611

DISTRIBUTED BY
GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY
CHESAPEAKE, VA 23320

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

COMPARE TO ACTIVE INGREDIENT IN
CHILDREN'S MUCINEX® CHEST CONGESTION*

NDC 59741-224-10

ASSURED™

CHILDREN'S

Chest
Congestion

Guaifenesin Oral
Solution, USP - Expectorant

AGES 4 +

Alcohol free

Grape flavor

Breaks up mucus

4 FL OZ
(118 mL)

Principal Display Panel - 118 mL Bottle Carton

CHEST CONGESTION
guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59741-224
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
Sodium Benzoate (UNII: OJ245FE5EU)
Saccharin Sodium (UNII: SB8ZUX40TY)
XANTHAN GUM (UNII: TTV12P4NEE)
Glycerin (UNII: PDC6A3C0OX)
Corn Syrup (UNII: 9G5L16BK6N)
Anhydrous Citric Acid (UNII: XF417D3PSL)
Grape (UNII: 6X543N684K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
SUCRALOSE (UNII: 96K6UQ3ZD4)
Water (UNII: 059QF0KO0R)

Product Characteristics
Color	BLUE (Bluish-Purple)	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59741-224-10	1 in 1 CARTON	05/16/2014	03/31/2016
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	05/16/2014	03/31/2016

Labeler - Bio-Pharm, Inc. (801652546)

Name	Address	ID/FEI	Business Operations
Establishment
Bio-Pharm, Inc.		801652546	MANUFACTURE(59741-224) , ANALYSIS(59741-224) , PACK(59741-224) , LABEL(59741-224)

Revised: 8/2018

Document Id: b5d3d935-f237-4d6a-85b4-e8a36fe03556

Set id: 62f95c43-3e82-4d75-818c-8d72c05495e5

Version: 2

Effective Time: 20180824

Bio-Pharm, Inc.