VANACOF AC- chlophedianol hcl, pyrilamine maleate liquid

VanaCof AC by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients

Each 30 mL contains:

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

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

Purpose

Cough Suppressant

Antihistamine

Uses

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

• cough due to minor throat and bronchial irritation
• runny nose
• sneezing
• itchy, watery eyes
• itching of the nose or throat

Warnings

Do not exceed recommended dosage

ASK DOCTOR

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
• cough that occurs with too much phlegm (mucus)
• a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers

WHEN USING

When using this poduct

• do not use more than directed
• marked drowsiness may occur
• alcohol, sedatives, and tranquilizers may increase drowsiness
• avoid alcoholics drinks
• 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 sleeplessnss 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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professhional 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 4 doses in any 24-hour period.
• Do not exceed recommended dosage.
• Use enclosed dose cup
• Keep dosage cup with product

• adults and children 12 years of age and over:

  60 mL every 6-8 hours

• children 6 to under 12 years of age:30: 30 mLevery 6-8 hours
• children under 6 years of age: Do not use

Other information

• each 30 mL contains: Sodium 12 mg
• tamper evident: Do not use if foil seal under cap is broken or missing.
• read all product information before using
• store at room temperature 68-77ºF (20-25ºC)
• avoid excessive heat and humidity

Inactive Ingredients

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

Questions or Comments?

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

PRINCIPAL DISPLAY PANEL

Distributed by:

GM Pharmaceuticals

Arlington, TX 76015

INGREDIENTS AND APPEARANCE

VANACOF AC 
chlophedianol hcl, pyrilamine maleate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58809-329
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL)	PYRILAMINE MALEATE	25 mg  in 30 mL
CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP)	CHLOPHEDIANOL HYDROCHLORIDE	12.5 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58809-329-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/01/2017

Labeler - GM Pharmaceuticals, Inc. (793000860)