Otc - Active Ingredient
Guaifenesin 200 mg / 5 mL – Purpose: Expectorant
Dextromethorphan HBr 30 mg / 5 mL – Purpose: Antitussive
Neotuss S/f Liquid
FDA Label NDC 12539-555
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Doral Pharmamedics Inc Dba A.g. Marin Pharmaceuticals for the product Neotuss S/f (NDC 12539-555). 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 otc - active ingredient, inactive ingredient, indications & usage, dosage & administration, otc - purpose, otc - when using, otc - keep out of reach of children, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Artificial and natural flavors, glycerin, hydroxyethylcellulose, menthol, methylparaben, propylene glycol, propylparaben, purified water, sorbitol, and sucralose.
Indications & Usage
Temporarily relieves cough due to minor bronchial irritations as may occur with the common cold. Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Adults and children over 12 years of age: Oral dose in one teaspoonful (5 mL) every 6-8 hours, or as directed by a physician.
Children 6 to under 12 years of age: 1/2 teaspoonful (2.5 mL) every 6-8 hours, or as directed by a physician.
Children under 6 years of age: Only as directed by a physician.
Dosage & Administration
Adults and children over 12 years of age: Oral dose in one teaspoonful (5 mL) every 6-8 hours, or as directed by a physician.
Children 6 to under 12 years of age: 1/2 teaspoonful (2.5 mL) every 6-8 hours, or as directed by a physician.
Children under 6 years of age: Only as directed by a physician.
Otc - Purpose
Expectorant and Antitussive (cough suppressant)
Otc - When Using
Temporarily relieves cough due to minor bronchial irritations as may occur with the common cold. Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Otc - Keep Out Of Reach Of Children
In case of accidental overdose, seek the advice of a health professional or contact a Poison Control Center immediately.
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 fever, rash, or persistent headache, consult a physician.
Do not take this product for persistent cough or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a physician.
Otc - Stop Use
Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug.
If you are uncertain whether your prescription drug contains a MAOI, consult a health professional before taking this product.
If pregnant or breast-feeding, ask a health professional before using this product.
Other Safety Information
Shake well before use.
Do not use this product if the seal is torn, broken or missing.
Pharmacist: Preserve and dispense in tight, light-resistant containers as defined in the USP.
Store between 15°-30°C (59°-86°F).
Package Label.Principal Display Panel
Package Label - Principal Display Panel
1 FL. OZ (30 mL) NDC: 12539-555-01
Neotuss S/f Label (Neotuss S F Drug Facts Label)
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