GUAIFENESIN DM by McKesson Corporation dba SKY Packaging GUAIFENESIN DM

Drug Details [pdf]

GUAIFENESIN DM- guaifenesin and dextromethorphan syrup
McKesson Corporation dba SKY Packaging

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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

HOW SUPPLIED: Guaifenesin Syrup and Dextromethorphan is a red, cherry flavored syrup supplied in the following oral dosage forms:

NDC: 63739-505-01 5 mL unit dose cup

NDC: 63739-505-10 Case contains 100 unit dose cups of 5 mL (63739-505-01) packaged in 10 trays of 10 unit dose cups each.

NDC: 63739-506-01 10 mL unit dose cup

NDC: 63739-506-10 Case contains 100 unit dose cups of 10 mL (63739-506-01) packaged in 10 trays of 10 unit dose cups each.

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

PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label

Delivers 5 mL

NDC: 63739-505-01

GUAIFENESIN SYRUP
and DEXTROMETHORPHAN

100 mg/10 mg per 5 mL

Package Not Child-Resistant

DISTRIBUTIONED BY

SKY Packaging

Memphis, TN 38141

SEE INSERT

F0638C050923

PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label

Delivers 10 mL

NDC: 63739-506-01

GUAIFENESIN SYRUP

and DEXTROMETHORPHAN

200 mg/20 mg per 10 mL

Package Not Child-Resistant

DISTRIBUTIONED BY

SKY Packaging

Memphis, TN 38141

See insert

GUAIFENESIN DM
guaifenesin and dextromethorphan syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63739-505
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (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: 63739-505-10	10 in 1 CASE	01/29/2024	12/31/2025
1		10 in 1 TRAY
1	NDC: 63739-505-01	5 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 Drug	M012	01/29/2024	12/31/2025

GUAIFENESIN DM
guaifenesin and dextromethorphan syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63739-506
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg in 10 mL
DEXTROMETHORPHAN (UNII: 7355X3ROTS) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg in 10 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCROSE (UNII: C151H8M554)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
WATER (UNII: 059QF0KO0R)

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: 63739-506-10	10 in 1 CASE	01/10/2024	10/31/2025
1		10 in 1 TRAY
1	NDC: 63739-506-01	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 Drug	M012	01/10/2024	12/31/2025

Labeler - McKesson Corporation dba SKY Packaging (140529962)

Revised: 1/2024

Document Id: f7ceb746-1c86-4b4c-bc42-7c7ca0cb7c02

Set id: 0826ed78-ce8a-4fea-81dc-57a2636a3197

Version: 3

Effective Time: 20240111