Cold And Flu Relief
FDA Label NDC 65808-024

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gmp Laboratories Of America, Inc for the product Cold And Flu Relief (NDC 65808-024). 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 uses, stop and ask a doctor if, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Uses

Relieves cold and flu symptoms of

  • headache
  • body aches
  • sore throat
  • fever and chills
  • congestion
  • runny nose
  • cough
  • nausea
  • vomiting
  • diarrhea

Stop And Ask A Doctor If

  • fever persists for more than 3 days or exceeds 102 degrees
  • if cough persists for more than one week, comes back after a few days, or is accompanied by fever, rash or persistent headache. Persistent cough or high fever may be a sign of a serious health condition.
  • do not take this product for persistent chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a physician

Directions

  • do not use if printed blister foil backing is torn or missing
  • adults and children over the age of 12, chew one tablet and allow to dissolve in the mouth every 30 minutes until symptoms inprove, then reduce to every 4 hours
  • children 6-12 use one half the adult dosage
  • not recommended for children under the age of 6

Other Information

  • for best results, take in a clean mouth
  • store at room temperature (65-80°F)

Inactive Ingredients

cellulose, croscarmellose sodium, dextrose, lactose, mangnesium stearate

* Please review the disclaimer below.