CURANEX DM- dextromethorphan hydrobromide 20 mg guaifenesin 400 mg tablet

CuraNEX DM by

Drug Labeling and Warnings

CuraNEX DM by is a Otc medication manufactured, distributed, or labeled by Wittman Pharma, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

■ take with a full glass of water

■ adults and children 12 years and over: 1 tablet

every 4 hours.

■ Do not take more than 6 tablets in 24 hours.

■ children under 12 years: do not use

Other information

WARNINGS

Do Not Use ~ 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 accompanied by too much phlegm (mucus)

■ persistent or chronic cough such as occurs~~

with smoking, asthma, chronic bronchitis,

or emphysema

■When using this product

do not exceed recommended dosage.

Stop use and ask a doctor if

■ cough persists more than 7 days, tends to recur,

or is accompanied by a fever, rash, or persistent

headache.

These could be signs of a serious condition.

■ if pregnant or breast-feeding, ask a health

professional before use.

INACTIVE INGREDIENT

Magnesium Stearate, Microcrystalline Cellulose,

Sodium Starch Glycolate

INDICATIONS & USAGE

Cough Suppressant and Expectorant

■ helps: loosen phlegm (mucus) and thin bronchial

secretions to rid the bronchial passageways of

bothersome mucus and make coughs more productive

■ temporarily relieves: ■ cough due to minor throat and

bronchial irritation associated with the common cold

■ the intensity of coughing ■ the impulse to cough to

help you get to sleep

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

■ In case of overdose, get medical help or contact

a Poison Control Center (1-800-222-1222) right

away.

PURPOSE

Purpose

(In each Immediate-re/ease tablet)

Dextromethorphan HBr 20 mg ...... Cough suppressant

Guaifenesin 400 mg ................................. Expectorant

ACTIVE INGREDIENT

Dextromethorphan HBr 20 mg ...... Cough suppressant

Guaifenesin 400 mg ................................. Expectorant

Drug Facts

Active ingredients Purpose

(In each Immediate-re/ease tablet)

Dextromethorphan HBr 20 mg ...... Cough suppressant

Guaifenesin 400 mg ................................. Expectorant

Use

■ helps: loosen phlegm (mucus) and thin bronchial

secretions to rid the bronchial passageways of

bothersome mucus and make coughs more productive

■ temporarily relieves: ■ cough due to minor throat and

bronchial irritation associated with the common cold

■ the intensity of coughing ■ the impulse to cough to

help you get to sleep

Warnings

Do Not Use ~ 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 accompanied by too much phlegm (mucus)

■ persistent or chronic cough such as occurs~~

with smoking, asthma, chronic bronchitis,

or emphysema

(Panel 2)

Warnings (continued)

When using this product

do not exceed recommended dosage.

Stop use and ask a doctor if

■ cough persists more than 7 days, tends to recur,

or is accompanied by a fever, rash, or persistent

headache.

These could be signs of a serious condition.

■ 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 (1-800-222-1222) right

away.

Directions

■ take with a full glass of water

■ adults and children 12 years and over: 1 tablet

every 4 hours.

■ Do not take more than 6 tablets in 24 hours.

■ children under 12 years: do not use

Other information

■ store between 15°-30°C (59°-86°F)

Inactive ingredients

Magnesium Stearate, Microcrystalline Cellulose,

Sodium Starch Glycolate

Questions or Comments?

call 1-352-549-9917, Mon-Fri: 9:00AM - 5:00 PM

INGREDIENTS AND APPEARANCE

CURANEX DM 
dextromethorphan hydrobromide 20 mg guaifenesin 400 mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83335-004
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg
DEXTROMETHORPHAN (UNII: 7355X3ROTS) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	13mm
Flavor		Imprint Code	DG
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83335-004-01	1 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	11/01/2023

Labeler - Wittman Pharma, Inc. (830980947)

Establishment
Name	Address	ID/FEI	Business Operations
Wittman Pharma, Inc.		830980947	manufacture(83335-004)