Otc - Active Ingredient
Dextromethorphan HBr 30 mg / 5 mL
Chlorpheniramine Maleate 4 mg / 5 mL
Phenylephrine HCl 7.5 mg / 5 mL
Neotuss Plus Liquid
FDA Label NDC 12539-779
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 Plus (NDC 12539-779). 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, otc - purpose, dosage & administration, otc - keep out of reach of children, otc - when using, otc - do not use, warnings and precautions, 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, citric acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium carboxymethylcellulose, sorbitol, and sucralose.
Otc - Purpose
Antitussive, Antihistamine, and Decongestant.
Temporarily relieves cough due to minor throat and bronchial irritations associated with the common cold or inhaled irritants. Helps thin bronchial passageways of bothersome mucus.
Temporarily relieves nasal congestion due to the common cold, sinusitis, hay fever or other respiratory allergies.
Temporarily relieves sneezing, itching of the nose or throat, and itchy watery eyes due to hay fever or other respiratory allergies.
Dosage & Administration
Adults and children over 12 years of age: One teaspoonful (5 mL) every 6-8 hours; do not exceed 4 teaspoonfuls in 24 hours period.
Children 6-12 years of age: 1/2 teaspoonful (2.5 mL) every 6-8 hours; do not exceed 2 teaspoonfuls in 24 hours period. Children under 6 years of age: Ask a doctor.
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.
Otc - When Using
Shake well before use.
Temporarily relieves cough due to minor throat and bronchial irritations associated with the common cold or inhaled irritants. Helps thin bronchial passageways of bothersome mucus.
Temporarily relieves nasal congestion due to the common cold, sinusitis, hay fever or other respiratory allergies.
Temporarily relieves sneezing, itching of the nose or throat, and itchy watery eyes due to hay fever or other respiratory allergies.
Otc - Do Not Use
Do not use this product if the seal is torn, broken or missing.
Do not take this product if you have a persistent or chronic cough, such as occurs with smoking, asthma, emphysema or when cough is accompanied by excessive secretions except under the advice and supervision of a physician.
Do not take other sedatives, tranquilizers or alcohol while taking this medication.
Do not use if you are taking monoamine oxidase inhibitors or other sympathomimetics.
If you are pregnant or breast-feeding, ask a health professional before using this product.
Warnings And Precautions
Sympathomimetic amines should be used with caution in patients with hypertension, diabetes mellitus, heart disease, peripheral vascular disease, increased intraocular pressure, hyperthyroidism or prostatic hypertrophy. May cause drowsiness. Sedatives and tranquilizers may increase the drowsiness effect.
Other Safety Information
Pharmacist: Preserve and dispense in tight-light resistance containers as defined in the USP.
Store between 15°-30°C (59°-86°F).
Do not accept this product if the safety seal is broken or missing.
Keep a box for information.
Warnings
Sympathomimetic amines should be used with caution in patients with hypertension, diabetes mellitus, heart disease, peripheral vascular disease, increased intraocular pressure, hyperthyroidism or prostatic hypertrophy. May cause drowsiness. Sedatives and tranquilizers may increase the drowsiness effect.
Indications & Usage
Adults and children over 12 years of age: One teaspoonful (5 mL) every 6-8 hours; do not exceed 4 teaspoonfuls in 24 hours period.
Children 6-12 years of age: 1/2 teaspoonful (2.5 mL) every 6-8 hours; do not exceed 2 teaspoonfuls in 24 hours period. Children under 6 years of age: Ask a doctor.
Temporarily relieves cough due to minor throat and bronchial irritations associated with the common cold or inhaled irritants. Helps thin bronchial passageways of bothersome mucus.
Temporarily relieves nasal congestion due to the common cold, sinusitis, hay fever or other respiratory allergies.
Temporarily relieves sneezing, itching of the nose or throat, and itchy watery eyes due to hay fever or other respiratory allergies.
Package Label.Principal Display Panel
Package Label - Principal Display Panel
1 FL. OZ (30 mL) NDC: 12539-779-01
Neotuss Plus 1 Fl.oz. (Neotuss Plus Drug Facts Label)
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