VanaCof 2

Manufacturer
GM Pharmaceuticals, INC
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:31:54

Label at a glance#

ProductVanaCof 2
Active ingredientDEXCHLORPHENIRAMINE MALEATE, CHLOPHEDIANOL HYDROCHLORIDE
Label structure10 sections

Indications and uses

■ temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: ■ runny nose ■ sneezing ■ itching of the nose or throat ■ itchy, watery eyes ■ cough due to minor throat and bronchial irritation

Dosage and administration

do not exceed recommended dosage. adults and children 12 years of age and over: 2 teaspoonfuls (10 mL) every 6 hours, not to exceed 8 teaspoonfuls (40 mL) in 24 hours. children 6 to under 12 years of age: 1 teaspoonful (5 mL) every 6 hours, not to exceed 4 teaspoonfuls (20 mL) in 24 hours. children under 6 years of age: consult a doctor.

Storage and handling

■ this packaging is child-resistant. ■ store at room temperature of 68°-86°F (20°-30°C) with excursions of 59°-86°F (15°-30°C)

Label contents#

Full prescribing information#

Active ingredients in each 5 mL (1 teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

Chlophedianol HCI 12.5 mg

Dexchlorpheniramine Maleate 1 mg

Purpose

OTC - PURPOSE SECTION

Cough Suppressant

Antihistamine

Uses

INDICATIONS & USAGE SECTION

■ temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

■ runny nose

■ sneezing

■ itching of the nose or throat

■ itchy, watery eyes

■ cough due to minor throat and bronchial irritation

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

■ a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema

■ a cough that occurs with too much phlegm (mucus)

■ a breathing problem such as emphysema or chronic bronchitis

■ trouble urinating due to an enlarged prostate gland

■ glaucoma

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

■ excitability may occur, especially in children

■ may cause marked drowsiness

■ alcohol, sedatives, and tranquilizers may increase the drowsiness effect

■ avoid alcoholic drinks

■ use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.

■ new symptoms occur

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

do not exceed recommended dosage.

adults and children 12 years of age and over:

2 teaspoonfuls (10 mL) every 6 hours, not to exceed 8 teaspoonfuls
(40 mL) in 24 hours.

children 6 to under 12 years of age:

1 teaspoonful (5 mL) every 6 hours, not to exceed 4 teaspoonfuls
(20 mL) in 24 hours.

children under 6 years of age:consult a doctor.

Other information

STORAGE AND HANDLING SECTION

■ this packaging is child-resistant.

■ store at room temperature of 68°-86°F (20°-30°C) with excursions of 59°-86°F (15°-30°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid anhydrous, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose

Questions?

OTC - QUESTIONS SECTION

Call 1-888-535-0305 9a.m. - 5p.m. CST

SPL UNCLASSIFIED SECTION

Distributed by: GM Pharmaceuticals, Inc. Fort Worth, TX 76118

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58809-190-16

VanaCof® 2

EACH 5 mL (1 TEASPOONFUL) CONTAINS:

Chlophedianol HCI..........................12.5 mg

Dexchlorpheniramine Maleate............1 mg

Cough Suppressant

Antihistamine

Sugar Free, Alcohol Free, Dye Free

Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

THIS BOTTLE IS NOT TO BE DISPENSED TO CONSUMER.

Dispense in a tight, light-resistant container with a child-resistant cap.

US Patent # 9,463,191

US Patent # 9,050,289

GM Pharmaceuticals, Inc.

16 fl. oz. (473 mL)

VanaCof 2 LabelVanaCof 2 Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2671454chlophedianol hydrochloride 12.5 MG / dexchlorpheniramine maleate 1 MG in 5 mL Oral SolutionPSN5
2671454chlophedianol hydrochloride 2.5 MG/ML / dexchlorpheniramine maleate 0.2 MG/ML Oral SolutionSCD5
2671454chlophedianol hydrochloride 12.5 MG / dexchlorpheniramine maleate 1 MG per 5 ML Oral SolutionSY5

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130358809190164GTIN-13: 0358809190164
EAN-13: 0358809190164
GTIN-12: 358809190164
UPC-A: 358809190164
GTIN storage (14 digits): 00358809190164
VanaCof_2_Daily_Med_V2.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
44893bf2-1be4-4e68-8bc4-bbb0f543085eProduct name120180830
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58809-190-16VanaCof 2473 mL in 1 BOTTLESOLUTION4735

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58809-190-16ML - Milliliter58809-190edef72bb-08fc-47b0-a927-d3361f5045bc12024-01-04

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58809-19058809-190-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VanaCof 2CHLOPHEDIANOL HCL, DEXCHLORPHENIRAMINE MALEATEGM Pharmaceuticals, INC0c7c6756-abb2-c10c-e063-6394a90a98632026-01-08WarningsExact identifier
ndc (package): 58809-190-16
ndc (product): 58809-190
ndc11 (package): 58809019016
spl id: 47e37a4b-be9d-3c99-e063-6394a90ac7c7
spl set id: 0c7c6756-abb2-c10c-e063-6394a90a9863

Reported adverse events (FAERS/openFDA)#

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