GUAIFENESIN AND DEXTROMETHORPHAN- guaifenesin and dextromethorphan syrup
Cardinal Health

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 (½ teaspoonful) every 4 hours
children under 2 years	ask a doctor

HOW SUPPLIED

Guaifenesin Syrup and Dextromethorphan is a red, cherry flavored syrup supplied in the following oral dosage forms: NDC 0121-0638-04 (4 fl oz bottle), NDC 0121-0638-08 (8 fl oz bottle), NDC 0121-0638-16 (16 fl oz bottle), NDC 0121-0638-05 (unit dose cups of 5 mL, 10 × 10's), and NDC 0121-0638-10 (unit dose cups of 10 mL, 10 × 10's).

STORAGE

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

R 06/06

Pharmaceutical Associates, Inc.

Greenville, SC 29605

Principal Display Panel

Guaifenesin Syrup and Dextromethorphan

200 mg/20 mg per 10 mL

5 Unit Dose Cups

GUAIFENESIN AND DEXTROMETHORPHAN
guaifenesin and dextromethorphan syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55154-9420(NDC:0121-0638)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55154-9420-5	5 in 1 BAG	07/01/1992	02/28/2019
1		10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	07/01/1992	02/28/2019

Labeler - Cardinal Health (188557102)

Name	Address	ID/FEI	Business Operations
Establishment
Cardinal Health		188557102	REPACK(55154-9420)

Revised: 7/2018

Document Id: 8eb2a6ca-68cf-4485-ad36-c29502ee7025

Set id: 50d43743-40a3-49f7-8eb7-c8e1f7ff0e70

Version: 3

Effective Time: 20180702

Cardinal Health