vanacof cp allergy / cough

vanacof cp allergy / cough
SPL v6
SPL
SPL Set ID 0bdea30a-39da-6611-e063-6394a90aa4cf
Route
oral
Published
Effective Date 2025-10-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
chlophedianol (12.5 mg) pyrilamine (25 mg)
Inactive Ingredients
sodium citrate sodium benzoate propylene glycol water sorbitol glycerin anhydrous citric acid saccharin sodium

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-12-06
Purpose

Cough Suppressant Antihistamine

Description

Chlophedianol HCl 12.5 mg Pyrilamine Maleate 25 mg

Medication Information

Uses

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

■ runny nose ■ itching of the nose or throat

■ sneezing ■ itchy, watery eyes

■ cough due to minor throat and bronchial irritation

Purpose

Cough Suppressant

Antihistamine

Directions

■ do not take more than 4 doses in any 24-hour period

■ dose as follows or as directed by a doctor ■ mL= milliliter

adults and children 12 years of age and over: 30 mL (2 TBSP) every 6 to 8 hours, not to exceed 120 mL (8 TBSP) per 24 hours
children 6 to under 12 years of age: 15 mL (1 TBSP) every 6 to 8 hours, not to exceed 60 mL (4 TBSP) per 24 hours
children under 6 years: consult a doctor.

Other Information

■ store at 20° to 30°C (68° to 86°F)

■ each 15 mL (1 TBSP) contains: Sodium 8.5 mg

Inactive Ingredients

citric acid anhydrous, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol

Description

Chlophedianol HCl 12.5 mg Pyrilamine Maleate 25 mg

Questions?

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

Section 42229-5

U.S. Pat: 9,463,191

Distributed by: GM Pharmaceuticals, Inc. Arlington, TX 76018

Section 51945-4

NDC 58809-189-08

VANACOF ®CP

Allergy / Cough

Each 15 mL (1 TBSP) contains:

Chlophedianol HCl .................... 12.5 mg

Pyrilamine Maleate ....................... 25 mg

Cough Suppressant • Antihistamine

Alcohol Free / Sugar Free / Gluten Free / Dye Free

GM Pharmaceuticals, Inc.

8 fl oz (237 mL)

Section 60561-8

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

When Using This Product

■ do not use more than directed ■ avoid alcoholic drinks

■ marked drowsiness may occur

■ alcohol, sedatives, and tranquilizers may increase drowsiness

■ be careful when driving a motor vehicle or operating machinery

■ excitability may occur, especially in children

Stop Use and Ask A Doctor If

■ nervousness, dizziness, or sleeplessness occurs

■ symptoms do not improve within 7 days, tend to recur, or are 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 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

■ glaucoma

■ difficulty in urination due to enlargement of the prostate gland

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

■ a breathing problem such as emphysema or chronic bronchitis

Active Ingredients (in Each 15 Ml (1tbsp))

Chlophedianol HCl 12.5 mg

Pyrilamine Maleate 25 mg

Structured Label Content

Uses

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

■ runny nose ■ itching of the nose or throat

■ sneezing ■ itchy, watery eyes

■ cough due to minor throat and bronchial irritation

Purpose

Cough Suppressant

Antihistamine

Directions

■ do not take more than 4 doses in any 24-hour period

■ dose as follows or as directed by a doctor ■ mL= milliliter

adults and children 12 years of age and over: 30 mL (2 TBSP) every 6 to 8 hours, not to exceed 120 mL (8 TBSP) per 24 hours
children 6 to under 12 years of age: 15 mL (1 TBSP) every 6 to 8 hours, not to exceed 60 mL (4 TBSP) per 24 hours
children under 6 years: consult a doctor.

Other Information (Other information)

■ store at 20° to 30°C (68° to 86°F)

■ each 15 mL (1 TBSP) contains: Sodium 8.5 mg

Inactive Ingredients (Inactive ingredients)

citric acid anhydrous, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol

Questions?

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

Section 42229-5 (42229-5)

U.S. Pat: 9,463,191

Distributed by: GM Pharmaceuticals, Inc. Arlington, TX 76018

Section 51945-4 (51945-4)

NDC 58809-189-08

VANACOF ®CP

Allergy / Cough

Each 15 mL (1 TBSP) contains:

Chlophedianol HCl .................... 12.5 mg

Pyrilamine Maleate ....................... 25 mg

Cough Suppressant • Antihistamine

Alcohol Free / Sugar Free / Gluten Free / Dye Free

GM Pharmaceuticals, Inc.

8 fl oz (237 mL)

Section 60561-8 (60561-8)

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

When Using This Product (When using this product)

■ do not use more than directed ■ avoid alcoholic drinks

■ marked drowsiness may occur

■ alcohol, sedatives, and tranquilizers may increase drowsiness

■ be careful when driving a motor vehicle or operating machinery

■ excitability may occur, especially in children

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

■ nervousness, dizziness, or sleeplessness occurs

■ symptoms do not improve within 7 days, tend to recur, or are 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 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

■ glaucoma

■ difficulty in urination due to enlargement of the prostate gland

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

■ a breathing problem such as emphysema or chronic bronchitis

Active Ingredients (in Each 15 Ml (1tbsp)) (Active Ingredients (in each 15 mL (1TBSP)))

Chlophedianol HCl 12.5 mg

Pyrilamine Maleate 25 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:43.675453 · Updated: 2026-03-14T23:13:02.501548