VANACOF DMX- dextromethorphan hydrobromide liquid

Vanacof DMX by

Drug Labeling and Warnings

Vanacof DMX 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 DMX

NDC: 58809-850-08

8 fl. Oz. (237 mL)

Drug Facts

Active ingredients

(in each 15 mL)

Dextromethorphan HBr 18 mg.........Cough Suppressant

Guaifenesin 396 mg......................................Expectorant

Phenylephrine HCl 10 mg................Nasal Decongestant

     

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Uses

■ temporarily relieves:

■ cough due to minor throat and bronchial irritation as

may occur with the common cold or inhaled irritants

■ the intensity of coughing

■ nasal congestion due to a cold

■ the impulse to cough to help you get to sleep

■ helps loosen phlegm (mucus) and thin bronchial

secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

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 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

■ symptoms 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.

■ nervousness, dizziness, or sleeplessness occurs

■ 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

■ 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 contains: Sodium 6 mg

■ this packaging is child-resistant.

■ read all product information before using

■ store at 20° to 30°C (68° to 86°F)

Inactive ingredients

citric acid, flavors, glycerin, L-menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

NDC: 58809-850-08
VANACOF DMX
Raspberry-Mint Flavor
8 fl oz (237 mL)

INGREDIENTS AND APPEARANCE

VANACOF DMX 
dextromethorphan hydrobromide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58809-850
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	396 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
LEVOMENTHOL (UNII: BZ1R15MTK7)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color		Score
Shape		Size
Flavor	RASPBERRY, MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58809-850-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/12/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	12/12/2019

Labeler - GM Pharmaceuticals, INC (793000860)