VANACOF DM- dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride liquid

VANACOF DM by

Drug Labeling and Warnings

VANACOF DM by is a Otc medication manufactured, distributed, or labeled by GM Pharmaceuticals, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

VANACOF DM 
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58809-555
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	18 mg  in 15 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	RASPBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58809-555-08	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	06/01/2013

Labeler - GM Pharmaceuticals, INC (793000860)