Tusicof Syrup
FDA Label NDC 52083-239

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kramer Novis for the product Tusicof (NDC 52083-239). 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, directions, other information, inactive ingredients, principal display panel - tusicof, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • temporarily relieves these symptoms occuring with a cold:
    • nasal congestion
    • cough due to minor throat and bronchial irritation

Directions

  • do not take more than 6 doses in any 24-hour period
    • EVERY 4 HOURS
  • Adults and Children 12 years and older: 5 mL (1 tsp)
  • Children under 12 years of age: consult physician

Other Information

  • Tamper evident feature: Do not use if inner seal is torn, broken or missing
  • Store at controlled room temperature 15-30°C (59-86°F)
  • Avoid excessive heat or humidity

Inactive Ingredients

Artificial and natural flavors, citric acid, glycerin, menthol, methylparaben, polyethylene glycol, propylparaben, purified water, sodium citrate and sucralose

Principal Display Panel - Tusicof

Principal Display Panel (Tusicof)

Principal Display Panel (Tusicof)

NDC 52083-239-16

TUSICOF

COUGH SUPPRESSANT - EXPECTORANT
NASAL DECONGESTANT

SUGAR & ALCOHOL FREE

NO SACCHARIN - NO SORBITOL - NO ASPARTAME - NO DYE - NO PPA

16 Fl. oz. (474 mL)
Kramer Novis

Pharmaceuticals within reach of patients

* Please review the disclaimer below.