VANACOF XP Cough / Chest Congestion

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 XP Cough / Chest Congestion
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure10 sections

Indications and uses

■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive ■ temporarily relieves: ■ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants ■ the intensity of coughing ■ the impulse to cough to help you get to sleep

Dosage and administration

■ do not take more than 6 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: 15 mL (1 TBSP) every 4 hours, not to exceed 90 mL (6 TBSP) per 24 hours children 6 to under 12 years of age: 7.5 mL (1/2 TBSP) every 4 hours, not to exceed 45 mL (3 TBSP) per 24 hours children under 6 years: consult a doctor.

Label contents#

Full prescribing information#

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

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 18 mg

Guaifenesin 396 mg

Purpose

OTC - PURPOSE SECTION

Cough Suppressant

Expectorant

Uses

INDICATIONS & USAGE SECTION

  • ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • ■ temporarily relieves:

■ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants

■ the intensity of coughing

■ the impulse to cough to help you get to sleep

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

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, chronic bronchitis, or emphysema
  • ■ a cough that occurs with too much phlegm (mucus)

When using this product

OTC - WHEN USING SECTION

do not use more than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

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 6 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:

15 mL (1 TBSP) every 4 hours, not to exceed 90 mL (6 TBSP) per 24 hours

children 6 to under 12 years of age:7.5 mL (1/2 TBSP) every 4 hours, not to exceed 45 mL (3 TBSP) per 24 hours
children under 6 years:consult a doctor.

Other information

OTHER SAFETY INFORMATION

■ each 15 mL (1 TBSP) contains: Sodium 6 mg

STORAGE AND HANDLING SECTION

■ store at 20° to 30°C (68° to 86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, flavors, glycerin, l-menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Tamper evident by foil seal under cap. Do no use if foil seal is broken or missing.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58809-187-08

VANACOF® XP

COUGH / CHEST CONGESTION

Each 15 mL (1 TBSP) contains:

Dextromethorphan HBr.....18 mg

Guaifenesin ....................396 mg

Cough Suppressant ■ Expectorant

Raspberry-Mint Flavor

Alcohol Free / Sugar Free / Gluten Free / Dye Free

VanaCof XP LabelVanaCof XP Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2671189dextromethorphan HBr 18 MG / guaiFENesin 396 MG in 15 mL Oral SolutionPSN5
2671189dextromethorphan hydrobromide 1.2 MG/ML / guaifenesin 26.4 MG/ML Oral SolutionSCD5
2671189dextromethorphan HBr 18 MG / guaifenesin 396 MG per 15 ML Oral SolutionSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130358809187089GTIN-13: 0358809187089
EAN-13: 0358809187089
GTIN-12: 358809187089
UPC-A: 358809187089
GTIN storage (14 digits): 00358809187089
Vanacof_XP.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
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
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58809-187-08VANACOF XP Cough / Chest Congestion237 mL in 1 BOTTLESOLUTION2375

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58809-187-08ML - Milliliter58809-187139e2d82-ddde-47d3-b9b3-f3449549743512024-01-04

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58809-18758809-187-08

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VANACOF XP Cough / Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINGM Pharmaceuticals, INC0b3a8cc1-a49f-e1e5-e063-6394a90a1c062026-01-08WarningsExact identifier
ndc (package): 58809-187-08
ndc (product): 58809-187
ndc11 (package): 58809018708
spl id: 47e37d77-7dd5-fa9d-e063-6294a90a0401
spl set id: 0b3a8cc1-a49f-e1e5-e063-6394a90a1c06

Reported adverse events (FAERS/openFDA)#

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