Neotuss Plus Cherry Flavor

Neotuss Plus Cherry Flavor
SPL v2
SPL
SPL Set ID 2f3c6b38-7236-899b-e063-6294a90aabde
Route
ORAL
Published
Effective Date 2025-02-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorpheniramine (300 mg) Dextromethorphan (1750 mg) Phenylephrine (4 mg)
Inactive Ingredients
Propylene Glycol Sorbitol Glycerin Citric Acid Methylparaben Propylparaben Sodium Carboxymethyl Starch Sucralose Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-28

Description

Dextromethorphan HBr 30 mg / 5 mL Chlorpheniramine Maleate 4 mg / 5 mL Phenylephrine HCl 7.5 mg / 5 mL


Medication Information

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.

Indications and 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.

Dosage and 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.

Description

Dextromethorphan HBr 30 mg / 5 mL Chlorpheniramine Maleate 4 mg / 5 mL Phenylephrine HCl 7.5 mg / 5 mL

Section 43685-7

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.

Section 50565-1

In case of accidental overdose seek the advice of a health professional or contact a Poison Control Center immediately.

Section 50567-7

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.

Section 50570-1

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.

Section 51727-6

Artificial and natural flavors, citric acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium carboxymethylcellulose, sorbitol, and sucralose.

Section 51945-4

Package Label - Principal Display Panel

1 FL. OZ (30 mL) NDC: 12539-779-01

Section 55105-1

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.

Section 55106-9

Dextromethorphan HBr 30 mg / 5 mL

Chlorpheniramine Maleate 4 mg / 5 mL

Phenylephrine HCl 7.5 mg / 5 mL

Section 60561-8

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.


Structured Label Content

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

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.

Section 43685-7 (43685-7)

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.

Section 50565-1 (50565-1)

In case of accidental overdose seek the advice of a health professional or contact a Poison Control Center immediately.

Section 50567-7 (50567-7)

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.

Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

Artificial and natural flavors, citric acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium carboxymethylcellulose, sorbitol, and sucralose.

Section 51945-4 (51945-4)

Package Label - Principal Display Panel

1 FL. OZ (30 mL) NDC: 12539-779-01

Section 55105-1 (55105-1)

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.

Section 55106-9 (55106-9)

Dextromethorphan HBr 30 mg / 5 mL

Chlorpheniramine Maleate 4 mg / 5 mL

Phenylephrine HCl 7.5 mg / 5 mL

Section 60561-8 (60561-8)

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.


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