VANACOF-8- chlophedianol hydrochloride and pyrilamine maleate liquid

VANACOF-8 by

Drug Labeling and Warnings

VANACOF-8 by is a Otc medication manufactured, distributed, or labeled by GM PHARMACEUTICALS,INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 15 mL (TBSP))	Purpose
Chlophedianol HCl 25 mg	Cough Suppressant
Pyrilamine Maleate 50 mg	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
• itching of the nose or throat
• itchy, watery eyes

Warnings

Do not exceed recommended dosage.

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.

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)
• glaucoma
• a breathing problem such as emphysema or chronic bronchitis
• difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product

• excitability may occur, especially in children
• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if:

• nervousness, dizziness or sleeplessness occurs
• symptoms do not improve within 7 days 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.

Directions

• Do not exceed recommended dosage.
• Use enclosed dosage cup or tablespoon (TBSP).

• Adults and children 12 years of age and over: 15 mL (1 TBSP) every 6 to 8 hours, not to exceed 60 mL (4 TBSP) in a 24 hour period.
• Children 6 to under 12 years of age: 7.5 mL (½ TBSP) every 6 to 8 hours, not to exceed 30 mL (2 TBSP) in a 24 hour period.
• Children under 6 years of age: Consult a doctor.

Other information

• Each 15 mL (TBSP) contains: Sodium 7 mg.
• Store at 59° to 86°F (15° to 30°C).

Inactive ingredients

Glycerin, Green Apple Flavor, Maltitol, Propylene Glycol, Purified Water, Sodium Saccharin, Sorbitol, Sucralose.

Questions? Comments?

Call 1-888-535-0305

SPL UNCLASSIFIED SECTION

Distributed by: GM Pharmaceuticals, Inc.
Arlington, TX 76015

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

NDC: 58809-350-04
VANACOF®- 8

Cough
Runny Nose / Sneezing

Each 15 mL (TBSP) contains:
Chlophedianol HCl 25 mg
Pyrilamine Maleate 50 mg

Cough Suppressant Antihistamine

Green Apple Flavor

Alcohol Free / Sugar Free / Gluten Free
Decongestant Free

4 fl. oz. (118 mL)

INGREDIENTS AND APPEARANCE

VANACOF-8 
chlophedianol hydrochloride and pyrilamine maleate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58809-350
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP)	CHLOPHEDIANOL HYDROCHLORIDE	25 mg  in 15 mL
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL)	PYRILAMINE MALEATE	50 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
MALTITOL (UNII: D65DG142WK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	APPLE (Green Apple)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58809-350-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	06/01/2013

Labeler - GM PHARMACEUTICALS,INC (793000860)