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

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 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.

Directions

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

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.

Fort Worth, TX 76118

KEEP LEAFLET AFTER OPENING

Rev. 02/23

PRINCIPAL DISPLAY PANEL

NDC 58809-555-08

VANACOF DM

Cough

Cold/Congestion

Raspberry Flavor

8 fl. oz. (240 mL)

Label

onsert-1

Onsert2

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: 8/2023
Document Id: 02abdf72-4dde-715e-e063-6394a90a91e7
Set id: 2ed699f2-d004-4fa9-8042-6c85a9ff69b6
Version: 8
Effective Time: 20230811
 
GM Pharmaceuticals, INC