Boxed Warning
Caution: do not use if imprinted seal under cap is broken or missing.
Guaifenesin Tablet
FDA Label NDC 24689-144
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Apnar Pharma Lp for the product Guaifenesin (NDC 24689-144). 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 boxed warning, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
