FDA Label for Guaifenesin And Dextromethorphan Hydrobromide
View Indications, Usage & Precautions
Guaifenesin And Dextromethorphan Hydrobromide Product Label
The following document was submitted to the FDA by the labeler of this product Apnar Pharma Lp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Boxed Warning
Caution: do not use if imprinted seal under cap is broken or missing
Otc - Active Ingredient
Drug Facts
Active Ingredients (per tablet)
Guaifenesin USP...................................... 400 mg
Dextromethorphan Hydrobromide USP...... 20 mg
Otc - Purpose
Purpose
Expectorant
Cough suppressant
Indications & Usage
Uses:
- Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold
- Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
- Helps make coughs more productive.
Warnings
WARNINGS
Do not use
- if 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 using this product.
- Persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis or emphysema
- Cough accompanied by excessive phegm (mucus)
- Symptons are accompanied by fever, rash or persistent headache
- cough persists for more than 1 week or tends to recur
- A persistent cough may be a sign of a serious condition
Ask a doctor before use if you have
Stop use and ask a doctor if
If pregnant or breast-feeding, ask a healthcare professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
In case of overdose, get medical help or contact poison control center immediately
Dosage & Administration
Directions
- Adults and children 12 years of age and over: take 1 tablet every 4 hours as needed
- Children 6 to 12 years of age: take 1/2 tablet every 4 hours as needed
- Children under 6 years of age: consult a doctor.
Do not exceed 6 doses in 24 hour period or as directed by a doctor
Storage And Handling
Other Information
- store at 15°-30°C (59°-86°F)
Inactive Ingredient
Inactive Ingredients
Microcrystalline cellulose, Croscarmellose sodium, Povidone, silicon dioxide, magnesium stearate
Otc - Questions
Questions or concerns?
- 1-855-642-2594
Other
Distributed by:
APNAR PHARMA LP
CHINO, CA, 91710
Rev.: 04/2022
Package Label.Principal Display Panel
APNAR PHARMA LP
NDC 24689-123-01
Guaifenesin and Dextromethorphan Hydrobromide Tablets 400 + 20mg- 20s tablets
APNAR PHARMA LP
NDC 24689-123-02
Guaifenesin and Dextromethorphan Hydrobromide Tablets 400 + 20mg- 500s tablets
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