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

  • 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 over2 teaspoonfuls (TSP) every 4 hours
children under 12 yearsDO NOT USE

Inactive ingredients

Citric Acid Anhydrous, USP; Sodium Citrate Dihydrate, USP; Sodium Saccharin, USP; Propylene Glycol, USP; Grape Flavor; Sorbitol Solution, USP; Glycerin, USP; Maltitol Solution, NF

Other information

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

Questions

1-877-250-3427

HOW SUPPLIED

Guaifenesin and Dextromethorphan Hydrobromide Syrup

  • NDC 72162-1670-2: 237 mL in a BOTTLE

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:72162-1670(NDC:58657-505)
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)  
MALTITOL (UNII: D65DG142WK)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (Grape Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72162-1670-2237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/04/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01206/14/201609/27/2024
Labeler - Bryant Ranch Prepack (171714327)
Registrant - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(72162-1670) , RELABEL(72162-1670)

Revised: 9/2024
 
Bryant Ranch Prepack