Active Ingredient(S)
Active ingredient (in each extended-release tablet)
Guaifenesin 600 mg
Active ingredient (in each extended-release tablet)
Guaifenesin 1200 mg
Guaifenesin Tablet, Extended Release
FDA Label NDC 65162-036
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Amneal Pharmaceuticals Llc for the product Guaifenesin (NDC 65162-036). 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 active ingredient(s), purpose, uses, do not use, ask a doctor before use if you have, stop use and ask a doctor if, pregnancy/breastfeeding, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Expectorant
Uses
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Do Not Use
- for children under 12 years of age
Ask A Doctor Before Use If You Have
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough accompanied by too much phlegm (mucus)
Stop Use And Ask A Doctor If
- cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.
Pregnancy/Breastfeeding
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 right away (1-800-222-1222).
Directions
600 mg
- do not crush, chew, or break tablet
- take with a full glass of water
- this product can be administered without regards for the timing of meals
- adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours.
- children under 12 years of age: do not use
- do not crush, chew, or break tablet
- take with a full glass of water
- this product can be administered without regards for the timing of meals
- adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.
- children under 12 years of age: do not use
1200 mg
Other Information
- Tamper evident: Do not use if printed foil under cap is broken or missing.
Storage
- store between 20° to 25°C (68° to 77°F)
Inactive Ingredients
carbomer, colloidal silicon dioxide, FD&C blue #1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and talc
Questions
1-877-835-5472 You may also report side effects to this phone number.
Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807
Rev. 12-2017-00
* Please review the disclaimer below.
