NEOTUSS PLUS- dextromethorphan hbr, chlorpheniramine maleate, phenylephrine hcl liquid

NeoTuss Plus by

Drug Labeling and Warnings

NeoTuss Plus by is a Otc medication manufactured, distributed, or labeled by DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals, DEXTRUM LABORATORIES INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Dextromethorphan HBr 30 mg / 5 mL

Chlorpheniramine Maleate 4 mg / 5 mL

Phenylephrine HCl 7.5 mg / 5 mL

INACTIVE INGREDIENT

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

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.

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.

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.

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.

PRINCIPAL DISPLAY PANEL

Package Label - Principal Display Panel

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

INGREDIENTS AND APPEARANCE

NEOTUSS PLUS 
dextromethorphan hbr, chlorpheniramine maleate, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12539-779
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	7.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	300 mg  in 5 mL
SORBITOL (UNII: 506T60A25R)	1750 mg  in 5 mL
GLYCERIN (UNII: PDC6A3C0OX)	500 mg  in 5 mL
CITRIC ACID (UNII: 2968PHW8QP)	10 mg  in 5 mL
METHYLPARABEN (UNII: A2I8C7HI9T)	9 mg  in 5 mL
PROPYLPARABEN (UNII: Z8IX2SC1OH)	1 mg  in 5 mL
SODIUM CARBOXYMETHYL STARCH (UNII: H8AV0SQX4D)	30 mg  in 5 mL
SUCRALOSE (UNII: 96K6UQ3ZD4)	7.5 mg  in 5 mL
WATER (UNII: 059QF0KO0R)	2331 mg  in 5 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12539-779-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/28/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	02/28/2025

Labeler - DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals (076007996)

Establishment
Name	Address	ID/FEI	Business Operations
DEXTRUM LABORATORIES INC.		007392322	manufacture(12539-779)