FDA Label for Mucus Relief
View Indications, Usage & Precautions
Mucus Relief Product Label
The following document was submitted to the FDA by the labeler of this product Aphena Pharma Solutions - Tennessee, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Tablet)
Guaifenesin 200 mg
Purpose
Expectorant
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive to rid the bronchial passageway of bothersome mucus and make cough 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 excessive phlegm (mucus)
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center right away.
In Case Of Pregnancy Or Breast Feeding Section
ask a health professional before use
Stop Use And Ask A Doctor
if cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache.These could be signs of serious illness
Directions:
- adults and children 12 years of age and over: take 1 to 2 tablets every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.
- children under 12 years: do not use
Other Information
- store at 15°-30°C (59°-86°F)
- TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Inactive Ingredients
colloidal silicon dioxide, FD&C RED#40(Al-lake), magnesium stearate, maltodextrin, microcrystalline cellulose, stearic acid, sodium starch glycolate
Questions Or Comments
call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Repackaging Information
Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
| Count | 200 mg |
| 3000 | 71610-098-18 |
Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
Repackaged by:
Cookeville, TN 38506
20180718JH
Principal Display Panel - 200 Mg
NDC 71610-098 - Guaifenesin 200 mg - Rx Only
* Please review the disclaimer below.