GUAIFENESIN AND DEXTROMETHORPHAN HBR- dextromethorphan hbr/guaifenesin liquid

Guaifenesin and Dextromethorphan HBr by

Drug Labeling and Warnings

Guaifenesin and Dextromethorphan HBr by is a Otc medication manufactured, distributed, or labeled by Belleview Biosciences. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Directions:
■ follow dosage below or use as directed by a physician
■ do not take more than 6 doses in any 24-hour period

WARNINGS

Warnings: Do not use if you are now taking a prescription monoamine oxidase inhibitor (MADI)
(certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease),or for 2
weeks after stopping the MADI drug.If you do not know if your
prescription drug contains an MAOI; ask a doctor or pharmacist before taking this product.t
Ask a doctor before use if you have
■ cough that occurs with too much phlegm (mucus)
■ cough that lasts or is chronic, such as occurs with smoking, asthma,
chronic bronchitis, or emphysema
Stop use and ask doctor if

■cough lasts more than 7 days., comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
■you are hypersensitive to any of the ingredients.

If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENT

Inactive Ingredients: Citric Acid, Flavor, Methylparaben, Monoammonium Glycyrrhizinate, Potassium Citrate, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, Sucralose

INDICATIONS & USAGE

Uses:

■ helps loosen phlegm(mucus) and thin bronchial secretions to make coughs more productive

■ temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get

medical help or contact a Poison Control Center right away.

PURPOSE

Purpose:

Cough Suppressant and Expectorant

ACTIVE INGREDIENT

Active Ingredient (in each 5 mL tsp)

Dextromethorphan HBr 10mg

Guaifenesin 100mg

PRINCIPAL DISPLAY PANEL

NDC: 84447-102-01

Guaifenesin/Dextromethorphan Oral Solution

Guaifenesin 100mg/5ml

Dextromethoprhan 10mg/5ml

PLEASE HANDLE CAREFULLY

Inactive Ingredients: Citric Acid, Flavor, Methylparaben, Monoammonium Glycyrrhizinate, Potassium Citrate, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, Sucralose

**Sugar, Alcohol, Gluten and Dye Free**

CAUTION:

FOR REPACKAGING ONLY

Store at controlled room temperature 15°-30°C (59°- 86°F)

INGREDIENTS AND APPEARANCE

GUAIFENESIN AND DEXTROMETHORPHAN HBR 
dextromethorphan hbr/guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84447-102
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
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
METHYLPARABEN (UNII: A2I8C7HI9T)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84447-102-01	200000 mL in 1 DRUM; Type 0: Not a Combination Product	07/20/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	07/20/2024

Labeler - Belleview Biosciences (131968803)

Establishment
Name	Address	ID/FEI	Business Operations
Belleview Biosciences		131968803	manufacture(84447-102) , analysis(84447-102) , label(84447-102)