Drug Facts Active Ingredient (In Each Extended-Release Tablet)
Guaifenesin 600 mg
Dr. Simi Mucus Relief Tablet, Extended Release
FDA Label NDC 85786-302
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Farmacias De Similares Tx Llc for the product Dr. Simi Mucus Relief (NDC 85786-302). 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 drug facts active ingredient (in each extended-release tablet), purpose, uses, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, 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
Warnings
.
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.
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
■ do not crush, chew, or break tablet
■ take with a full glass of water
■ this product can be administered without regard 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
Other Information
■ store between 20-25°C (68-77°F)
■ retain carton for complete product information and warnings
Inactive Ingredients
carbomer homopolymer type B, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.
Questions Or Comments?
855-280-1079
Principal Display Panel
NDC: 85786-302-40
DR. SIMI
Mucus Relief
Guaifenesin Extended-Release
Tablets, 600 mg
Expectorant
12 hour
• Relieves Chest congestion
• Thins & Loosens mucus
• Immediate and Extended Release
40 EXTENDED-RELEASE TABLETS
†Compare to the active ingredient in Mucinex®
†This product is not manufactured or distributed by Reckitt Benckiser, distributor of Mucinex®
DO NOT USE IF BLISTER UNITS ARE TORN OR BROKEN
Made in India
Distributed by:
FARMACIAS DE SIMILARES TX LLC
800 Brazos St Ste 260, Austin, TX, 78701, USA
[email protected]
www.drsimi.com
* Please review the disclaimer below.
