GUAIFENESIN DM by A-S Medication Solutions GUAIFENESIN DM

GUAIFENESIN DM by

Drug Labeling and Warnings

GUAIFENESIN DM by is a Otc medication manufactured, distributed, or labeled by A-S Medication Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GUAIFENESIN DM- guaifenesin and dextromethorphan syrup 
A-S Medication Solutions

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.

----------

GUAIFENESIN DM

Non-Narcotic, Alcohol Free
Expectorant/Cough Suppressant

DESCRIPTION

Each 5 mL (1 teaspoonful) contains:
Guaifenesin	100 mg
Dextromethorphan Hydrobromide	10 mg

Inactive Ingredients: Citric acid, FD&C Red No. 40, flavoring, glycerin, menthol, purified water, sodium benzoate, sodium citrate, sodium saccharin, and sucrose. 

Sodium Content: 4 mg/5 mL

USES

• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

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

• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if

• cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
• you are hypersensitive to any of the 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.

Professional Note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

DIRECTIONS: Follow dosage below or use as directed by a physician.

• do not take more than 6 doses in any 24-hour period.

age	dose
adults and children; 12 years and over	10 mL (2 teaspoonfuls); every 4 hours
children 6 years to; under 12 years	5 mL (1 teaspoonful); every 4 hours
children 2 years to; under 6 years	2.5 mL (1/2 teaspoonful); every 4 hours
children under 2 years	ask a doctor

Product: 50090-3492

STORAGE: Keep tightly closed.  Store at controlled room temperature, 20°-25°C (68°-77°F) [See USP].  Protect from light. 

MANUFACTURED BY

Pharmaceutical Associates, Inc.
Greenville, SC 29605
www.paipharma.com 

R11/16

GUAIFENESIN and DEXTROMETHORPHAN

GUAIFENESIN DM 
guaifenesin and dextromethorphan syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50090-3492(NDC: 0121-1276)
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCROSE (UNII: C151H8M554)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50090-3492-0	100 in 1 CASE	06/20/2018	09/30/2019
1		10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/01/1992	09/30/2019

Labeler - A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Business Operations
A-S Medication Solutions		830016429	RELABEL(50090-3492)

Revised: 1/2020

Document Id: de17cdae-15e3-46dd-87bd-ce14c25f004b

34390-5

Set id: 765e1568-2531-4731-a5e9-d1eea324cf16

Version: 11

Effective Time: 20200118

 

A-S Medication Solutions