Tussi Pres B Syrup
FDA Label NDC 52083-237
7 label sections · Submitted to the FDA by Kramer Novis · 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 Tussi Pres B (NDC 52083-237). 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 drug facts, active ingredients (in each 5 ml tsp), purposes, dosage & administration, other safety information, inactive ingredient, packaging, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients (In Each 5 Ml Tsp)
Brompheniramine Maleate, 4 mg
Dextromethorphan HBr, 20 mg
Phenylephrine HCl, 10 mg
Purposes
Antihistamine
Cough Suppressant
Nasal Decongestant
Dosage & Administration
Directions do not take more than 6 doses in any 24-hour period
| EVERY 4 HOURS | Adults and Children 12 years of age and over 5mL (1tsp) |
| Children 6 years to under 12 years 2.5mL (1/2 tsp) | |
| Children under 6 years consult physician | |
| Children under 2 years do not use |
Other Safety Information
Other information: • Tamper evident: Do not use if inner seal is torn, broken or missing • Store at controlled room temperature 15°-30°C (59°-86°F) • Avoid excess heat or humidity
Inactive Ingredient
Inactive ingredients: Citric acid, flavor, hydroxyethylcellulose, methylparaben, propylene glycol, propylparaben, purified water and sucralose
Packaging
Image Description (Label1)
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