GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE- guaifenesin and dextromethorphan hydrobromide syrup 
Bryant Ranch Prepack

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Guaifenesin and Dextromethorphan Hydrobromide Syrup

Active ingredients

Dextromethorphan HBr, USP 10 mg
Guaifenesin, USP 100 mg

Purpose

Cough suppressant
Expectorant

Uses

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

Stop use and ask a doctor if

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

adults and children 12 years and over2 teaspoonfuls (TSP) every 4 hours
children 6 to 12 years of age1 teaspoonful (TSP) every 4 hours
children under 6 yearsDO 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

Questions

1-877-250-3427

HOW SUPPLIED

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

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

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

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

Label
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE 
guaifenesin and dextromethorphan hydrobromide syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72162-2277(NDC:58657-504)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72162-2277-2237 mL in 1 BOTTLE; Type 0: Not a Combination Product04/22/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01204/01/2024
Labeler - Bryant Ranch Prepack (171714327)
Registrant - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(72162-2277) , RELABEL(72162-2277)

Revised: 4/2024
Document Id: 7824357b-cb68-4028-b234-f41f9a920a6b
Set id: 9a77465c-6d3a-4399-9734-ad22e4b435db
Version: 1
Effective Time: 20240422
 
Bryant Ranch Prepack