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
Curanex Dm
FDA Label NDC 83335-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wittman Pharma, Inc. for the product Curanex Dm (NDC 83335-004). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding dosage & administration, warnings, inactive ingredient, indications & usage, otc - keep out of reach of children, otc - purpose, otc - active ingredient, drug facts, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Otc - 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.
Otc - Purpose
Purpose
(In each Immediate-re/ease tablet)
Dextromethorphan HBr 20 mg ...... Cough suppressant
Guaifenesin 400 mg ................................. Expectorant
Otc - 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?
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