Drug Facts
Active ingredient (in each extended-release tablet)
- Guaifenesin 1200 mg
Dr Simi Mucus Relief Expectorant Tablet, Extended Release
FDA Label NDC 85786-301
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 Expectorant (NDC 85786-301). 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, 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
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
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 accompained by too much phlegm (mucus).
Stop Use And Ask A Doctor If
- Cough lasts more than 7 days, come 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
Keep out of reach of children
Overdosage
in case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- Do not crush, chew, or break tablet.
- Take with a full glass of water.
- This product can be administered without regard for timing of meals.
Dosage & Administration
- Adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.
- Childrens under 12 years of age: do not use.
Other Information
- Store between 20-25°C (68-77°F)
- TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
Inactive Ingredients
Carbomer homopolymer type B, Hypromellose, Magnesium stearate, Microcrystalline cellulose, Sodium starch glycolate.
Questions Or Comments?
(855)-280-1079
Other
Distributed by: FARMACIAS DE SIMILARES TX LLC
800 Brazos St Ste 260, Austin, TX, 78701, USA.
[email protected]
www.drsimi.com
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Package Label.Principal Display Panel
DR SIMI
NDC 85786-301-14
Maximum Strength / Expectorant
Mucus Relief
Guaifenesin 1200 mg
Relieves Chest Congestion
Thins and Loosens Mucus
Immediate and Extended Release
14 Tablets
Extended Release
Bi-Layer Tablets
* Please review the disclaimer below.
