Label: CURANEX DM- dextromethorphan hydrobromide 20 mg guaifenesin 400 mg tablet
- NDC Code(s): 83335-004-01
- Packager: Wittman Pharma, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 4, 2024
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- Official Label (Printer Friendly)
- DOSAGE & ADMINISTRATION
-
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
-
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
- PURPOSE
- ACTIVE INGREDIENT
-
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 tabletProduct 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)