FDA Label for Guaifenesin
View Indications, Usage & Precautions
Guaifenesin 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
Active Ingredient (per tablet)
Guaifenesin USP 400 mg
Otc - Purpose
Purpose
Expectorant
Indications & Usage
Use
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
- helps make coughs more productive
Warnings
Warnings
Ask doctor before use if you have
- persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis or emphysema
- cough accompanied by excessive phlegm (mucus)
- Symptoms are accompanied by fever, rash or persistent headache
- cough persists for more than 1 week or tends to recur
Stop use and ask a doctor if
A persistent cough may be a sign of a serious condition
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 under 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 a 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
Maltodextrin, Povidone, Silicon dioxide and Stearic acid
Otc - Questions
Questions or concerns?
- 1-855-642-2594
Other
Manufactured by:
APNAR PHARMA LLP
East Windsor, NJ 08520
Made in USA
Rev.: 05/2022
Package Label.Principal Display Panel
NDC 24689-144-01
Guaifenesin Tablets 400 mg
Expectorant
100 Tablets
* Please review the disclaimer below.
