Guaifenesin and Dextromethorphan Hydrobromide Syrup

Guaifenesin and Dextromethorphan Hydrobromide Syrup

Drug Labeling and Warnings

Drug Details

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GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE- guaifenesin and dextromethorphan hydrobromide syrup 
Method Pharmaceuticals

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.

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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

Principal Display Panel

Method Pharmaceuticals

NDC: 58657-505-08

Guaifenesin and Dextromethorphan Hydrobromide Syrup

100 mg/10 mg/5 mL

Expectorant

Cough Suppressant

Grap Flavor

Non Drowsy Alcohol Free

FOR AGES 12 AND UP

8 fl. oz. (237 mL)

Manufactured For:

Method Pharmaceuticals, LLC

Fort Worth, TX 76118 Rev. 06/2016

PDP

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE 
guaifenesin and dextromethorphan hydrobromide syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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: 58657-505-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/14/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/14/2016
Labeler - Method Pharmaceuticals (060216698)

Revised: 8/2016
 
Method Pharmaceuticals


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