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
Drug Facts
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, 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
- A persistent cough may be a sign of a serious condition
Stop use and ask a doctor if
If pregnant or breast-feeding, ask a health 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 a 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 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
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 : 24689-122-01
Guaifenesin Tablets 400mg-20's Tablets
APNAR PHARMA LP
NDC : 24689-122-02
Guaifenesin Tablets 400mg-500's Tablets
* Please review the disclaimer below.
