NeoTuss Plus

Manufacturer
DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals | DEXTRUM LABORATORIES INC.
Effective date
2025-12-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:26:06

Label at a glance#

ProductNeoTuss Plus
Active ingredientCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 30 mg / 5 mL

Chlorpheniramine Maleate 4 mg / 5 mL

Phenylephrine HCl 7.5 mg / 5 mL

INACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

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 SECTION

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 SECTION

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

OTC - WHEN USING SECTION

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 SECTION

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 SECTION

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 SECTION

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 SECTION

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 1 Fl.Oz.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2167750chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG / phenylephrine HCl 7.5 MG in 5 mL Oral SolutionPSN2
2167750chlorpheniramine maleate 0.8 MG/ML / dextromethorphan hydrobromide 6 MG/ML / phenylephrine hydrochloride 1.5 MG/ML Oral SolutionSCD2
2167750chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG / phenylephrine HCl 7.5 MG per 5 ML Oral SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12539-779-01NeoTuss Plus30 mL in 1 BOTTLELIQUID302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
12539-779-16ML - Milliliter12539-779a0a1b661-0c49-4b6f-b7e1-0697fd98b26812025-05-14

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
12539-77912539-779-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NeoTuss PlusDEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLDORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals2fabd782-14dc-1d1b-e063-6394a90af4282025-12-18WarningsExact identifier
ndc (product): 12539-779
NeoTuss PlusDEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLDORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals2f3c6b38-7236-899b-e063-6294a90aabde2025-12-18WarningsExact identifier
ndc (package): 12539-779-01
ndc (product): 12539-779
ndc11 (package): 12539077901
spl id: 463c4add-041a-5e18-e063-6294a90adf9e
spl set id: 2f3c6b38-7236-899b-e063-6294a90aabde

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.