CURANEX DM- dextromethorphan hydrobromide 20 mg guaifenesin 400 mg tablet 
Wittman Pharma, Inc.

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CuraNEX DM

■ 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

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.

Magnesium Stearate, Microcrystalline Cellulose,

Sodium Starch Glycolate

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.

■ In case of overdose, get medical help or contact

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

away.

Purpose

(In each Immediate-re/ease tablet)

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

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

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

Panel 1

Panel 2

CURANEX DM 
dextromethorphan hydrobromide 20 mg guaifenesin 400 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83335-004
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
DEXTROMETHORPHAN (UNII: 7355X3ROTS) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize13mm
FlavorImprint Code DG
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83335-004-011 in 1 BOTTLE; Type 0: Not a Combination Product11/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01211/01/2023
Labeler - Wittman Pharma, Inc. (830980947)
Establishment
NameAddressID/FEIBusiness Operations
Wittman Pharma, Inc.830980947manufacture(83335-004)

Revised: 4/2024
Document Id: 1547fa22-281e-34ef-e063-6394a90aee62
Set id: 0b62981b-5918-26d1-e063-6394a90a15f8
Version: 2
Effective Time: 20240404
 
Wittman Pharma, Inc.