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Chest Congestion by Bio-Pharm, Inc.

Dosage form: solution
Ingredients: Guaifenesin 100mg in 5mL
Labeler: Bio-Pharm, Inc.
NDC Code: 59741-224

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 yearsdo not use
4 years to under 6 years1/2 TSP to 1 TSP
6 years to under 12 years1 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)

CHEST CONGESTION 
guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59741-224
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (Guaifenesin) Guaifenesin100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Sodium Benzoate 
Saccharin Sodium 
XANTHAN GUM 
Glycerin 
Corn Syrup 
Anhydrous Citric Acid 
Grape 
FD&C BLUE NO. 1 
D&C RED NO. 33 
SUCRALOSE 
Water 
Product Characteristics
ColorBLUE (Bluish-Purple) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:59741-224-101 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/16/2014
Labeler - Bio-Pharm, Inc. (801652546)
Establishment
NameAddressID/FEIOperations
Bio-Pharm, Inc.801652546MANUFACTURE(59741-224), ANALYSIS(59741-224), PACK(59741-224), LABEL(59741-224)

Revised: 05/2014
 
Bio-Pharm, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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