GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE syrup

Guaifenesin and Dextromethorphan Hydrobromide by

Drug Labeling and Warnings

Guaifenesin and Dextromethorphan Hydrobromide by is a Otc medication manufactured, distributed, or labeled by Bryant Ranch Prepack. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Dextromethorphan HBr, USP 10 mg
Guaifenesin, USP 100 mg

Purpose

Cough suppressant
Expectorant

Uses

• temporarily relieves cough due to minor throat and bronchial
  irritation
• helps loosen phlegm (mucus) and thin bronchial secretions
  to make coughs more productive

Warnings

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• persistent cough or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema
• cough accompanied by excessive phlegm (mucus)

Stop use and ask a doctor if

• cough lasts more than 7 days or occurs with fever, rash, or
  headaches that lasts. This could be a sign of a serious condition
• hypersensitive to any ingredients

If pregnant or breast-feeding,

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.

Directions

• do not take more than 6 doses in any 24-hour period. This adult product is not intended for use in children under 12 years of age

• adults and children 12 years and over: 2 teaspoonfuls (TSP) every 4 hours
• children 6 to 12 years of age: 1 teaspoonful (TSP) every 4 hours
• children under 6 years: DO NOT USE

TAMPER-EVIDENT

Do not use if seal cap is broken or missing.

Inactive ingredients

Anhydrous citric acid, dextrose, FD&C Red #40, flavor, gylcerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate

Other information

• store at room temperature 20°-25°C (68°-77°F)
• each 5 mL contains: sodium 3 mg

Questions

1-877-250-3427

HOW SUPPLIED

Dextromethorphan HBr, USP 10 mg - Guaifenesin, USP 100 mg.

• NDC: 72162-2277-2: 237 mL in a Bottle.

Store at room temperature 20°-25°C (68°-77°F)

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504

PRINCIPAL DISPLAY PANEL

Guaifenesin and Dextromethorphan Hydrobromide Syrup 100 mg/10 mg/5 mL

INGREDIENTS AND APPEARANCE

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE 
guaifenesin and dextromethorphan hydrobromide syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72162-2277(NDC:58657-504)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
SODIUM BENZOATE (UNII: OJ245FE5EU)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72162-2277-2	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/22/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	04/01/2024

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Business Operations
Bryant Ranch Prepack		171714327	REPACK(72162-2277) , RELABEL(72162-2277)