VANACOF 2- chlophedianol hcl, dexchlorpheniramine maleate solution

VanaCof 2 by

Drug Labeling and Warnings

VanaCof 2 by is a Otc medication manufactured, distributed, or labeled by GM Pharmaceuticals, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients in each 5 mL (1 teaspoonful)

Chlophedianol HCI 12.5 mg

Dexchlorpheniramine Maleate 1 mg

Purpose

Cough Suppressant

Antihistamine

Uses

■ temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

■ runny nose

■ sneezing

■ itching of the nose or throat

■ itchy, watery eyes

■ cough due to minor throat and bronchial irritation

Warnings

Ask a doctor before use if you have

■ a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema

■ a cough that occurs with too much phlegm (mucus)

■ a breathing problem such as emphysema or chronic bronchitis

■ trouble urinating due to an enlarged prostate gland

■ glaucoma

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

■ excitability may occur, especially in children

■ may cause marked drowsiness

■ alcohol, sedatives, and tranquilizers may increase the drowsiness effect

■ avoid alcoholic drinks

■ use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

■ cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent 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

do not exceed recommended dosage.

• adults and children 12 years of age and over:

  2 teaspoonfuls (10 mL) every 6 hours, not to exceed 8 teaspoonfuls ; (40 mL) in 24 hours.

• children 6 to under 12 years of age:

  1 teaspoonful (5 mL) every 6 hours, not to exceed 4 teaspoonfuls ; (20 mL) in 24 hours.

• children under 6 years of age: consult a doctor.

Other information

■ this packaging is child-resistant.

■ store at room temperature of 68°-86°F (20°-30°C) with excursions of 59°-86°F (15°-30°C)

Inactive ingredients

citric acid anhydrous, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose

Questions?

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

SPL UNCLASSIFIED SECTION

Distributed by: GM Pharmaceuticals, Inc. Fort Worth, TX 76118

PRINCIPAL DISPLAY PANEL

NDC: 58809-190-16

VanaCof® 2

EACH 5 mL (1 TEASPOONFUL) CONTAINS:

Chlophedianol HCI..........................12.5 mg

Dexchlorpheniramine Maleate............1 mg

Cough Suppressant

Antihistamine

Sugar Free, Alcohol Free, Dye Free

Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

THIS BOTTLE IS NOT TO BE DISPENSED TO CONSUMER.

Dispense in a tight, light-resistant container with a child-resistant cap.

US Patent # 9,463,191

US Patent # 9,050,289

GM Pharmaceuticals, Inc.

16 fl. oz. (473 mL)

INGREDIENTS AND APPEARANCE

VANACOF 2 
chlophedianol hcl, dexchlorpheniramine maleate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58809-190
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXCHLORPHENIRAMINE MALEATE (UNII: B10YD955QW) (DEXCHLORPHENIRAMINE - UNII:3Q9Q0B929N)	DEXCHLORPHENIRAMINE MALEATE	1 mg  in 5 mL
CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP)	CHLOPHEDIANOL HYDROCHLORIDE	12.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SUCRALOSE (UNII: 96K6UQ3ZD4)
GLYCERIN (UNII: PDC6A3C0OX)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)

Product Characteristics
Color		Score
Shape		Size
Flavor	RASPBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58809-190-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/14/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	12/14/2023

Labeler - GM Pharmaceuticals, INC (793000860)