Vanacof Dm

Vanacof Dm
SPL v13
SPL
SPL Set ID 2ed699f2-d004-4fa9-8042-6c85a9ff69b6
Route
ORAL
Published
Effective Date 2025-10-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (18 mg) Guaifenesin (200 mg) Phenylephrine (10 mg)
Inactive Ingredients
Anhydrous Citric Acid Glycerin Propylene Glycol Water Trisodium Citrate Dihydrate Saccharin Sodium Sorbitol Sodium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-06-01

Description

Vanacof DM NDC 58809-555-08 8 fl. Oz. (240 mL)

Purpose

Cough Suppressant Expectorant Nasal Decongestant


Medication Information

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Description

Vanacof DM NDC 58809-555-08 8 fl. Oz. (240 mL)

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
Section 42229-5

Vanacof DM

NDC 58809-555-08

8 fl. Oz. (240 mL)

Directions
  • do not take more than 6 doses in any 24-hour period
  • use enclosed dosage cup or tablespoon (TBSP)
  • dose as follows or as directed by a doctor
Adults and children 12 years of age and over: 15 mL (1 TBSP) every 4 hours, not to exceed 90 mL (6 TBSP) in a 24 hour period.
Children 6 to under 12 years of age: 7.5 mL (1/2 TBSP) every 4 hours, not to exceed 45 mL (3 TBSP) in a 24 hour period.
Children under 6 years of age: Consult a doctor.

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.

Other Information
  • Each 15 mL (TBSP) contains: Sodium 8 mg.
  • read all product information before using
  • store at 20-30°C (68-86°F)
Inactive Ingredients

citric acid anhydrous, glycerin, masking agent, propylene glycol, purified water, raspberry flavor, sodium benzoate, sodium citrate dihydrate, sodium saccharin, sorbitol

Questions Or Comments?

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

Distributed by:

GM Pharmaceuticals, Inc.

Arlington, TX 76018

KEEP LEAFLET AFTER OPENING

Rev. 09/25

Principal Display Panel

NDC 58809-555-08



VANACOF DM



Cough



Cold/Congestion



Raspberry Flavor



8 fl. oz. (240 mL)

When Using This Product

do not use more than directed

Stop Use and Ask A Doctor If:
  • nervousness, dizziness or sleeplessness occurs
  • symptoms do not improve within 7 days or are accompanied by a fever, rash or persistent headache. A persistant cough may be a sign of a serious condition.
  • new symptoms occur
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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

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
Active Ingredients (in Each 15 Ml (1 Tbsp))

Dextromethorphan HBr 18 mg

Guaifenesin 200 mg

Phenylephrine HCl 10 mg


Structured Label Content

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
Section 42229-5 (42229-5)

Vanacof DM

NDC 58809-555-08

8 fl. Oz. (240 mL)

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Directions
  • do not take more than 6 doses in any 24-hour period
  • use enclosed dosage cup or tablespoon (TBSP)
  • dose as follows or as directed by a doctor
Adults and children 12 years of age and over: 15 mL (1 TBSP) every 4 hours, not to exceed 90 mL (6 TBSP) in a 24 hour period.
Children 6 to under 12 years of age: 7.5 mL (1/2 TBSP) every 4 hours, not to exceed 45 mL (3 TBSP) in a 24 hour period.
Children under 6 years of age: Consult a doctor.

Do Not Use (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.

Other Information (Other information)
  • Each 15 mL (TBSP) contains: Sodium 8 mg.
  • read all product information before using
  • store at 20-30°C (68-86°F)
Inactive Ingredients (Inactive ingredients)

citric acid anhydrous, glycerin, masking agent, propylene glycol, purified water, raspberry flavor, sodium benzoate, sodium citrate dihydrate, sodium saccharin, sorbitol

Questions Or Comments? (Questions or Comments?)

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

Distributed by:

GM Pharmaceuticals, Inc.

Arlington, TX 76018

KEEP LEAFLET AFTER OPENING

Rev. 09/25

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 58809-555-08



VANACOF DM



Cough



Cold/Congestion



Raspberry Flavor



8 fl. oz. (240 mL)

When Using This Product (When using this product)

do not use more than directed

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)
  • nervousness, dizziness or sleeplessness occurs
  • symptoms do not improve within 7 days or are accompanied by a fever, rash or persistent headache. A persistant cough may be a sign of a serious condition.
  • new symptoms occur
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Ask A Doctor Before Use If You Have (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
Active Ingredients (in Each 15 Ml (1 Tbsp)) (Active ingredients (in each 15 mL (1 TBSP)))

Dextromethorphan HBr 18 mg

Guaifenesin 200 mg

Phenylephrine HCl 10 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)