Vanacof® 2

Drug Facts

Composition & Product

Active Ingredients

Dexchlorpheniramine (1 mg) Chlophedianol (12.5 mg)

Inactive Ingredients

Water Propylene Glycol Sodium Benzoate Sorbitol Solution Anhydrous Citric Acid Sucralose Glycerin Trisodium Citrate Dihydrate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-12-14

Medication Information

Purpose

Cough Suppressant

Antihistamine

Description

Chlophedianol HCI 12.5 mg Dexchlorpheniramine Maleate 1 mg

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

Section 42229-5

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

Section 51945-4

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)

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.

Questions?

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

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)

Active Ingredients

Chlophedianol HCI 12.5 mg

Dexchlorpheniramine Maleate 1 mg

Inactive Ingredients

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

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.

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

Structured Label Content

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

Section 42229-5 (42229-5)

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

Section 51945-4 (51945-4)

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)

Purpose

Cough Suppressant

Antihistamine

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.

Questions?

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

Other Information (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)

Active Ingredients (Active ingredients)

Chlophedianol HCI 12.5 mg

Dexchlorpheniramine Maleate 1 mg

Inactive Ingredients (Inactive ingredients)

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

When Using This Product (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 (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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", "42229-5": "Distributed by: GM Pharmaceuticals, Inc. Fort Worth, TX 76118", "51945-4": "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)", "Purpose": "Cough Suppressant Antihistamine", "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.", "Questions?": "Call 1-888-535-0305 9a.m. - 5p.m. CST", "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)", "Active ingredients": "Chlophedianol HCI 12.5 mg Dexchlorpheniramine Maleate 1 mg", "Inactive ingredients": "citric acid anhydrous, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose", "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.", "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"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information