Mucus Relief Tablet
FDA Label NDC 71610-098

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aphena Pharma Solutions - Tennessee, Llc for the product Mucus Relief (NDC 71610-098). 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, keep out of reach of children, in case of pregnancy or breast feeding section, stop use and ask a doctor, directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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:

Count200 mg
300071610-098-18

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:

Aphena Pharma Solutions (TN)

Aphena Pharma Solutions (TN)


Cookeville, TN 38506

20180718JH

Principal Display Panel - 200 Mg

NDC 71610-098 - Guaifenesin 200 mg - Rx Only

Bottle Label 200 mg (71610 0098 18)

Bottle Label 200 mg (71610 0098 18)

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