FDA.reportPublic FDA data

VanaTab DM

Manufacturer
GM Pharmaceuticals, Inc.
Effective date
2024-01-09
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 21:15:21

Label at a glance#

ProductVanaTab DM
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure14 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 nasal congestion due to a cold

Dosage and administration

do not take more than 6 doses in any 24-hour period dose as follows or as directed by a doctor adults and children 12 years of age and over: 2 caplets every 4 hours children 6 to under 12 years of age: 1 caplet every 4 hours children under 6 years of age: consult a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Each caplet contains:

Dextromethorphan HBr 9 mg

Guaifenesin 198 mg

Phenylephrine HCl 5 mg

Purpose

OTC - PURPOSE SECTION

Cough Suppressant

Expectorant

Nasal Decongestant

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
  • nasal congestion due to a cold

Warnings

WARNINGS SECTION

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • a cough that lasts or is chronic such as occurs with smoking
  • asthma, or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • difficulty in urination due to enlargement of the prostate gland

OTC - WHEN USING SECTION

When using this poduct do not use more than directed

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • nervousness, dizziness or sleeplessnss occurs
  • sysmtoms do not improve within 7 days 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 6 doses in any 24-hour period
  • dose as follows or as directed by a doctor
adults and children 12 years of age and over:

2 caplets every 4 hours

children 6 to under 12 years of age:1 caplet every 4 hours
children under 6 years of age:consult a doctor

Other information

OTHER SAFETY INFORMATION

  • Store at 68-77 oF (20-25 oC).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, magnesium stearate, menthol, microcrystalline cellulose, polyethylene glycol, polysorbate, polyvinyl alcohol, pregelatinized starch, silicon dioxide, talc

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

princpal display labelprincpal display labelonsert-1onsert-1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58809-198VANATAB DM (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [GM PHARMACEUTICALS, INC.]7Legacy NDC20240110_4b2077b4-9d12-1fa0-e054-00144ff88e88.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58809-198-60EA - Each58809-198a8aea27a-1847-4a57-a307-05e5dd6a7f6f12017-08-11

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
58809-19858809-198-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYSORBATE 207T1F30V5YHIACT
GUAIFENESIN495W7451VQACTIB
MAGNESIUM STEARATE70097M6I30IACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
STARCH, PREGELATINIZED CORNO8232NY3SJIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TALC7SEV7J4R1UIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MENTHOL 1-PROPYLENE GLYCOL CARBONATE, (-)-2WL8FX4EEZIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT

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
3c3075c1-7389-d02c-e063-6394a90ae90f4b2077b4-9d12-1fa0-e054-00144ff88e882025-08-12WarningsExact identifier
spl set id: 4b2077b4-9d12-1fa0-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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