Mucus Relief Tablet
FDA Label NDC 69517-005

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Healthlife Of Usa Llc for the product Mucus Relief (NDC 69517-005). 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 caplet), purpose, uses, warnings, ask a doctor before use if you have, when using this product, 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

Active Ingredient (In Each Caplet)

Guaifenesin 400 mg

Purpose

Expectorant

Uses

  • Temporary symptomatic relief from congested chests and cough.

Warnings

A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache, consult a doctor.

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).

When Using This Product

  • Do not exceed recommended dosage.
  • Do not consume alcohol, benzodiazepines or opioids.

Stop Use And Ask A Doctor If

cough lasts for more than 7 days please consult your physician or healthcare provider.

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 (1-800-222-1222) right away.

Directions

  • Adults and children 12 years of age and over: take 1 caplet a day.
  • Children under 12 years:Do not use.
  • Do not exceed 4 doses in 24 hours.

Other Information

  • Store at 25°C (77°F) excursions between 15°-30°C (59°-86°F).
  • Keep in a dry place and do not expose to heat.
  • Read all product information before using.
  • TEMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive Ingredients

Croscarmellose Sodium, Maltodextrin, Polyvinyl Pyrroliidone (PVPK30), Collidal Silicon Dioxide, Microcrystalline Cellulose (PH-102), Stearic Acid Powder

Questions Or Comments?

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Principal Display Panel-200'S Count

200 (Label 200)

200 (Label 200)

Principal Display Panel-300'S Count

300 (Label 300)

300 (Label 300)

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