VANACOF DM- dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride liquid 
GM Pharmaceuticals, INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Vanacof DM

Vanacof DM

NDC 58809-555-08

8 fl. Oz. (240 mL)

Active ingredients (in each 15 mL (TBSP))

Dextromethorphan HBr 18 mg

Guaifenesin 200 mg

Phenylephrine HCl 10 mg 

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

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

Warnings

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.

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

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
  • new symptoms occur

headache. A persistent cough may be a sign of a serious condition.

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.

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.

Other information

  • Each 15 mL (TBSP) contains: Sodium 8 mg.
  • store at 68-86°F (20-30°C).

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 76015

KEEP LEAFLET AFTER OPENING

Rev. 09/16

PRINCIPAL DISPLAY PANEL

NDC 58809-55-08
VANACOF DM
Cough
Cold/Congestion
Raspberry Flavor
8 fl. oz. (240 mL)

PRINCIPAL DISPLAY PANEL
NDC 58809-55-08
VANACOF DM
Cough
Cold/Congestion
Raspberry Flavor
8 fl. oz. (240 mL)

PRINCIPAL DISPLAY PANEL
NDC 58809-55-08
VANACOF DM
Cough
Cold/Congestion
Raspberry Flavor
8 fl. oz. (240 mL)

PRINCIPAL DISPLAY PANEL
NDC 58809-55-08
VANACOF DM
Cough
Cold/Congestion
Raspberry Flavor
8 fl. oz. (240 mL)

VANACOF DM 
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-555
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE18 mg  in 15 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Product Characteristics
Color    Score    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58809-555-08240 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/01/2013
Labeler - GM Pharmaceuticals, INC (793000860)

Revised: 1/2021
 
GM Pharmaceuticals, INC