VANATAB AC- chlophedianol hcl, pyrilamine maleate tablet

VanaTab AC by

Drug Labeling and Warnings

VanaTab 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

(in each caplet)

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.

• adults and children 12 years of age and over:

  2 caplets every 6-8 hours

• children 6 to under 12 years of age: 1 caplet every 6-8 hours
• children under 6 years of age: Do not use

Other information

• tamper evident: Do not use if foil seal under cap is broken or missing.
• read all product information before using
• Store at 68-77 oF (20-25 oC).
• avoid excessive heat and humidity

Inactive Ingredients

croscarmellose sodium, magnesium stearate, microcrystalline cellulose, silicon dioxide

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

VANATAB AC 
chlophedianol hcl, pyrilamine maleate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58809-330
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
CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP)	CHLOPHEDIANOL HYDROCHLORIDE	12.5 mg

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	white (white/off white)	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	33
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58809-330-60	60 in 1 BOTTLE, PLASTIC; 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)