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 Method Pharmaceuticals. 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 under 12 years: DO 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

INGREDIENTS AND APPEARANCE

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE 
guaifenesin and dextromethorphan hydrobromide syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58657-505
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)
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
Shape		Size
Flavor	GRAPE (Grape Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58657-505-08	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/14/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/14/2016

Labeler - Method Pharmaceuticals (060216698)