Vanacof ® - DailyMed Details

Vanacof ®

SPL v13

SPL

SPL Set ID cf3886ab-62b3-497a-a587-18cbfbaf3634

Route

ORAL

Published

Effective Date 2023-02-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Chlophedianol (12.5 mg) Dexchlorpheniramine (1 mg) Pseudoephedrine (30 mg)

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2008-04-22

Description

Drug Facts

Purpose

Cough Suppressant Antihistamine Nasal Decongestant

Medication Information

Purpose

Cough Suppressant

Antihistamine

Nasal Decongestant

Description

Drug Facts

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
- nasal congestion
- reduces swelling of nasal passages
cough due to minor throat and bronchial irritation

Section 42229-5

Drug Facts

Warnings

Do not exceed recommended dosage.

Directions

Do not exceed recommended dosage.

adults and children 12 years of age and over:	2 teaspoonfuls every 6 hours, not to exceed 8 teaspoonfuls in 24 hours.
children 6 to under 12 years of age:	1 teaspoonful every 6 hours, not to exceed 4 teaspoonfuls in 24 hours.
children under 6 years of age:	consult a doctor.

Other Information

this package 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 Or Comments?

Call 1-888-535-0305 9a.m. – 5p.m. CST

Do Not Use This Product

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

Principal Display Panel

NDC 58809-999-01

VanaCof ^®

Each 5 mL (1 TEASPOONFUL) CONTAINS:

Chlophedianol Hydrochloride ..... 12.5 mg

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

Pseudoephedrine Hydrochloride ..... 30mg

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

nervousness, dizziness, or sleeplessness occur
cough or nasal congestion 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 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 Are

taking sedatives or tranquilizers.

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
heart disease
high blood pressure
thyroid disease
diabetes

Active Ingredients (in Each 5 Ml Teaspoonful)

Chlophedianol Hydrochloride 12.5 mg

Dexchlorpheniramine Maleate 1 mg

Pseudoephedrine Hydrochloride 30 mg

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
- nasal congestion
- reduces swelling of nasal passages
cough due to minor throat and bronchial irritation

Section 42229-5 (42229-5)

Drug Facts

Purpose

Cough Suppressant

Antihistamine

Nasal Decongestant

Warnings

Do not exceed recommended dosage.

Directions

Do not exceed recommended dosage.

adults and children 12 years of age and over:	2 teaspoonfuls every 6 hours, not to exceed 8 teaspoonfuls in 24 hours.
children 6 to under 12 years of age:	1 teaspoonful every 6 hours, not to exceed 4 teaspoonfuls in 24 hours.
children under 6 years of age:	consult a doctor.

Other Information (Other information)

this package 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 (Inactive ingredients)

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

Questions Or Comments? (Questions or Comments?)

Call 1-888-535-0305 9a.m. – 5p.m. CST

Do Not Use This Product (Do not use this product)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 58809-999-01

VanaCof ^®

Each 5 mL (1 TEASPOONFUL) CONTAINS:

Chlophedianol Hydrochloride ..... 12.5 mg

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

Pseudoephedrine Hydrochloride ..... 30mg

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)

nervousness, dizziness, or sleeplessness occur
cough or nasal congestion 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 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 Are (Ask a doctor before use if you are)

taking sedatives or tranquilizers.

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
heart disease
high blood pressure
thyroid disease
diabetes

Active Ingredients (in Each 5 Ml Teaspoonful) (Active ingredients (in each 5 mL teaspoonful))

Chlophedianol Hydrochloride 12.5 mg

Dexchlorpheniramine Maleate 1 mg

Pseudoephedrine Hydrochloride 30 mg

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 nasal congestion reduces swelling of nasal passages cough due to minor throat and bronchial irritation", "42229-5": "Drug Facts", "Purpose": "Cough Suppressant Antihistamine Nasal Decongestant", "Warnings": "Do not exceed recommended dosage.", "Directions": "Do not exceed recommended dosage. adults and children 12 years of age and over: 2 teaspoonfuls every 6 hours, not to exceed 8 teaspoonfuls in 24 hours. children 6 to under 12 years of age: 1 teaspoonful every 6 hours, not to exceed 4 teaspoonfuls in 24 hours. children under 6 years of age: consult a doctor.", "Other information": "this package 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 or Comments?": "Call 1-888-535-0305 9a.m. – 5p.m. CST", "Do not use this product": "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", "PRINCIPAL DISPLAY PANEL": "NDC 58809-999-01 VanaCof ® Each 5 mL (1 TEASPOONFUL) CONTAINS: Chlophedianol Hydrochloride ..... 12.5 mg Dexchlorpheniramine Maleate ......... 1 mg Pseudoephedrine Hydrochloride ..... 30mg", "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": "nervousness, dizziness, or sleeplessness occur cough or nasal congestion 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 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 are": "taking sedatives or tranquilizers.", "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 heart disease high blood pressure thyroid disease diabetes", "Active ingredients (in each 5 mL teaspoonful)": "Chlophedianol Hydrochloride 12.5 mg Dexchlorpheniramine Maleate 1 mg Pseudoephedrine Hydrochloride 30 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:02.559677 · Updated: 2026-03-14T23:13:02.501548