FDA.reportPublic FDA data

VANACOF CP Allergy / Cough

Manufacturer
GM Pharmaceuticals, INC
Effective date
2025-10-14
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:38:53

Label at a glance#

ProductVANACOF CP Allergy / Cough
Active ingredientCHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE
Label structure11 sections

Indications and uses

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

Dosage and administration

■ do not take more than 4 doses in any 24-hour period ■ dose as follows or as directed by a doctor ■ mL= milliliter adults and children 12 years of age and over: 30 mL (2 TBSP) every 6 to 8 hours, not to exceed 120 mL (8 TBSP) per 24 hours children 6 to under 12 years of age: 15 mL (1 TBSP) every 6 to 8 hours, not to exceed 60 mL (4 TBSP) per 24 hours children under 6 years: consult a doctor.

Storage and handling

■ store at 20° to 30°C (68° to 86°F) ■ each 15 mL (1 TBSP) contains: Sodium 8.5 mg

Label contents#

Full prescribing information#

Active Ingredients (in each 15 mL (1TBSP))

OTC - ACTIVE INGREDIENT SECTION

Chlophedianol HCl 12.5 mg

Pyrilamine Maleate 25 mg

Purpose

OTC - PURPOSE SECTION

Cough Suppressant

Antihistamine

Uses

INDICATIONS & USAGE SECTION

■ temporarily relieves these symptoms due to the common cold, hay fever or other upper respiratory allergies:
■ runny nose ■ itching of the nose or throat
■ sneezing ■ 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
■ glaucoma
■ difficulty in urination due to enlargement of the prostate gland
■ a cough that occurs with too much phlegm (mucus)
■ a breathing problem such as emphysema or chronic bronchitis

Ask a doctor before use if you are

OTC - ASK DOCTOR SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

■ do not use more than directed ■ avoid alcoholic drinks
■ marked drowsiness may occur
■ alcohol, sedatives, and tranquilizers may increase drowsiness
■ be careful when driving a motor vehicle or operating machinery
■ excitability may occur, especially in children

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ nervousness, dizziness, or sleeplessness occurs
■ symptoms do not improve within 7 days, tend to recur, or are 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 take more than 4 doses in any 24-hour period
■ dose as follows or as directed by a doctor ■ mL= milliliter

adults and children 12 years of age and over:30 mL (2 TBSP) every 6 to 8 hours, not to exceed 120 mL (8 TBSP) per 24 hours
children 6 to under 12 years of age:15 mL (1 TBSP) every 6 to 8 hours, not to exceed 60 mL (4 TBSP) per 24 hours
children under 6 years:consult a doctor.

Other information

STORAGE AND HANDLING SECTION

■ store at 20° to 30°C (68° to 86°F)
■ each 15 mL (1 TBSP) contains: Sodium 8.5 mg

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid anhydrous, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol

Questions?

OTC - QUESTIONS SECTION

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

OTHER SAFETY INFORMATION

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

SPL UNCLASSIFIED SECTION

U.S. Pat: 9,463,191

Distributed by: GM Pharmaceuticals, Inc. Arlington, TX 76018

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58809-189-08

VANACOF ®CP

Allergy / Cough

Each 15 mL (1 TBSP) contains:

Chlophedianol HCl .................... 12.5 mg

Pyrilamine Maleate ....................... 25 mg

Cough Suppressant • Antihistamine

Alcohol Free / Sugar Free / Gluten Free / Dye Free

GM Pharmaceuticals, Inc.

8 fl oz (237 mL)

VanaCof CPVanaCof CP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2672917chlophedianol HCl 25 MG / pyrilamine maleate 50 MG in 30 mL Oral SolutionPSN6
2672917chlophedianol hydrochloride 0.833 MG/ML / pyrilamine maleate 1.67 MG/ML Oral SolutionSCD6
2672917chlophedianol hydrochloride 12.5 MG / pyrilamine maleate 25 MG per 15 ML Oral SolutionSY6
2672917chlophedianol hydrochloride 25 MG / pyrilamine maleate 50 MG per 30 ML Oral SolutionSY6

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130358809189083GTIN-13: 0358809189083
EAN-13: 0358809189083
GTIN-12: 358809189083
UPC-A: 358809189083
GTIN storage (14 digits): 00358809189083		Vanacof_CP.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
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58809-189-08VANACOF CP Allergy / Cough237 mL in 1 BOTTLESOLUTION2376

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58809-189-08ML - Milliliter58809-18932b0176d-0a17-474e-ba92-d46e67b8ee7912024-01-04

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
58809-18958809-189-08

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
SODIUM CITRATE1Q73Q2JULRIACT
SODIUM BENZOATEOJ245FE5EUIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
CHLOPHEDIANOL HYDROCHLORIDE69QQ58998YACTIB
PYRILAMINE MALEATER35D29L3ZAACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52024-10-09full-release2026-06-01 00:23:52

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 CP Allergy / CoughCHLOPHEDIANOL HCL, PYRILAMINE MALEATEGM Pharmaceuticals, INC0bdea30a-39da-6611-e063-6394a90aa4cf2025-10-14WarningsExact identifier
ndc (package): 58809-189-08
ndc (product): 58809-189
ndc11 (package): 58809018908
spl id: 41209869-f054-7352-e063-6294a90aa5ab
spl set id: 0bdea30a-39da-6611-e063-6394a90aa4cf

Reported adverse events (FAERS/openFDA)#

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