Active Ingredient (In Each Tablet)
Guaifenesin 200mg
Guaifenesin 200mg Tablet
FDA Label NDC 71679-148
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Health Pharma Usa Llc for the product Guaifenesin 200mg (NDC 71679-148). 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 (in each tablet), purpose, uses, warnings, stop use and ask a doctor if, if pregnant or breast- feeding,, keep out of reach of children., directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Expectorant
Guaifenesin 200 mg Tablets
Uses
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageway of bothersome mucus and make coughs more productive
Warnings
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 last more than 7 days, come back or is accompanied by fever, rash, or persistent headache. There could be signs of a serious illness.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
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.
Directions:
- Do not take more than 6 doses in any 24-hour period.
- This product is not intended for use in children under 12 years of age
- Adults & children 12 years and over: 1 to 2 tablets every 4 hours
- Children under 12 years: do not use
Other Information:
- Store at 15°C-30°C (59°F-86°F)
Inactive Ingredients:
Colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate
Manufactured & Distributed by:
Health Pharma
Rahway, NJ 07065
www.healthpharma.us
Questions Or Comments?
Call toll free 1-844-832-1138 Monday through Friday 9AM – 5PM EST
Principal Display Panel
NDC 71679-148-02
Guaifenesin
200 mg
200 TABLETS
Mucus Relief 200mg 200s (Label 71679 148 02 Mucusrelief Guai200mg 200s)
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