GUAIFENESIN SYRUP AND DEXTROMETHORPHAN syrup

Guaifenesin Syrup and Dextromethorphan by

Drug Labeling and Warnings

Guaifenesin Syrup and Dextromethorphan by is a Otc medication manufactured, distributed, or labeled by Natco Pharma USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Non-Narcotic - Alcohol Free

DRUG FACTS

Active Ingredient (in each 5 mL cup)                                                                                                                    Purpose
Guaifenesin, USP 100mg .............................................................................................................................. Expectorant
Dextromethorphan HBr, USP 10mg ...................................................................................................... Cough Suppressant

Active Ingredient (in each 10 mL cup)                                                                                                                   Purpose
Guaifenesin, USP 200mg .............................................................................................................................. Expectorant
Dextromethorphan HBr, USP 20mg .......................................................................................................Cough Suppressant

Inactive Ingredients

Anhydrous citric acid, dextrose, FD&C Red No. 40, flavor, glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate.

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) or for two weeks after stopping the MAOI drug.

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

Ask a doctor or pharmacist before use if you are taking any other drug

Stop use and ask a doctor if

your cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache.
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 (1-800-222-1222)

DOSAGE & ADMINISTRATION

DIRECTIONS:

Age	Dose
Adults and children; 12 years and over	10 mL every 4 hours Max dose is 60mL in 24-hours
Children under 12 years of age	Ask a doctor

HOW SUPPLIED

HOW SUPPLIED: 

Each 5 mL of Guaifenesin Syrup and Dextromethorphan contains Guaifenesin 100mg and Dextromethorphan Hydrobromide 10mg and is supplied in the following oral dosage forms:

NDC: 69339-149-05 (1) unit dose cup 5mL
NDC: 69339-149-19 100 (10x10) unit dose cups 5mL

Each 10 mL of Guaifenesin Syrup and Dextromethorphan
contains Guaifenesin 200mg and Dextromethorphan
Hydrobromide 20mg and is supplied in the following oral
dosage forms:

NDC: 69339-150-01 (1) unit dose cup 10mL
NDC: 69339-150-19 100 (10x10) unit dose cups 10mL

STORAGE AND HANDLING

Other Information
Store at controlled room temperature 20-25ºC (68-77ºF)
Do not refrigerate
Keep tightly closed
Each 5mL contains sodium 3mg
Each 10mL contains sodium 6mg
Fruit punch flavor
Do not use if lid seal is open or damaged
See top of cup for lot number and expiration date

SPL UNCLASSIFIED SECTION

Questions or comments?
Call 201-786-6500

Dash Pharmaceuticals LLC
Upper Saddle River, NJ 07458

DP-UD-PI-AT-[117893] Rev 08/20

PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label

Delivers 5 mL
NDC: 69339-149-05

GUAIFENESIN SYRUP &

DEXTROMETHORPHAN HBr

100 mg/10 mg per 5 mL

For Institutional Use Only

3 69339 14905 8

Lot # 111

Exp: 09/22/2020

See Insert

Dash Pharmaceuticals LLC

Upper Saddle River, NJ 07458

DASH-

DOSE

PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label

Delivers 10 mL
NDC: 69339-150-01

GUAIFENESIN SYRUP &

DEXTROMETHORPHAN HBr

200 mg/20 mg per 10 mL

For Institutional Use Only

3 69339 15001 6

Lot # 111

Exp: 09/22/2020

See Insert

Dash Pharmaceuticals LLC

Upper Saddle River, NJ 07458

DASH-

DOSE

INGREDIENTS AND APPEARANCE

GUAIFENESIN SYRUP AND DEXTROMETHORPHAN 
guaifenesin syrup and dextromethorphan syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69339-149
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 HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
DEXTROSE (UNII: IY9XDZ35W2)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MENTHOL (UNII: L7T10EIP3A)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	FRUIT PUNCH	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69339-149-19	10 in 1 CASE	10/19/2020
1		10 in 1 TRAY
1	NDC: 69339-149-05	5 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 Drug	M012	10/19/2020

GUAIFENESIN SYRUP AND DEXTROMETHORPHAN 
guaifenesin syrup and dextromethorphan syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69339-150
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 HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
DEXTROSE (UNII: IY9XDZ35W2)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MENTHOL (UNII: L7T10EIP3A)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	FRUIT PUNCH	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69339-150-19	10 in 1 CASE	10/19/2020
1		10 in 1 TRAY
1	NDC: 69339-150-01	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 Drug	M012	10/19/2020

Labeler - Natco Pharma USA LLC (079590418)