FDA.reportPublic FDA data

VanaCof AC

Manufacturer
GM Pharmaceuticals, Inc.
Effective date
2017-03-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:17:09

Label at a glance#

ProductVanaCof AC
Active ingredientPYRILAMINE MALEATE, CHLOPHEDIANOL HYDROCHLORIDE
Label structure14 sections

Indications and uses

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

Dosage and administration

Do not take more than 4 doses in any 24-hour period. Do not exceed recommended dosage. Use enclosed dose cup Keep dosage cup with product adults and children 12 years of age and over: 60 mL every 6-8 hours children 6 to under 12 years of age:30 30 mLevery 6-8 hours children under 6 years of age: Do not use

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Each 30 mL contains:

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

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

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:

  • cough due to minor throat and bronchial irritation
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

Warnings

WARNINGS SECTION

Do not exceed recommended dosage

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • 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
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this poduct

  • do not use more than directed
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholics drinks
  • 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 sleeplessnss 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professhional 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.
  • Do not exceed recommended dosage.
  • Use enclosed dose cup
  • Keep dosage cup with product
adults and children 12 years of age and over:

60 mL every 6-8 hours

children 6 to under 12 years of age:3030 mLevery 6-8 hours
children under 6 years of age:Do not use

Other information

OTHER SAFETY INFORMATION

  • each 30 mL contains: Sodium 12 mg
  • tamper evident: Do not use if foil seal under cap is broken or missing.
  • read all product information before using
  • store at room temperature 68-77ºF (20-25ºC)
  • avoid excessive heat and humidity

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions or Comments?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Distributed by:

GM Pharmaceuticals

Arlington, TX 76015

PDPPDP

Drug FactsDrug Facts

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130358809329083GTIN-13: 0358809329083
EAN-13: 0358809329083
GTIN-12: 358809329083
UPC-A: 358809329083
GTIN storage (14 digits): 00358809329083		PDP.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58809-329-082021-01-19C16284748780-19d75b9d0-aee8-f424-e053-dadaa90a57ceVanaCof AC
58809-329-082020-01-31C16284748780-19d75b9d0-aee8-f424-e053-dadaa90a57ceVanaCof AC

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58809-329-08ML - Milliliter58809-32943527954-cb79-49c8-86de-e8f51fe4bbf912017-08-11

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
58809-32958809-329-08

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
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
PYRILAMINE MALEATER35D29L3ZAACTIB
CHLOPHEDIANOL HYDROCHLORIDE69QQ58998YACTIB
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SUCRALOSE96K6UQ3ZD4IACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
SORBITOL506T60A25RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

Source Document#

Source XML · Source PDF

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
b9443f27-160b-97eb-e053-2a95a90a195b4b42dbb6-f765-6276-e054-00144ff8d46c2021-01-19WarningsExact identifier
spl set id: 4b42dbb6-f765-6276-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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