VANAPAIN PM- choline salicylate, diphenhydramine hydrochloride liquid

Vanapain PM by

Drug Labeling and Warnings

Vanapain PM by is a Otc medication manufactured, distributed, or labeled by GM Pharmaceuticals, Inc., Woodfield Pharmaceutical, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients

(per 57 mL)

Choline Salicylate (NSAID*) 870 mg

Diphenhydramine Hydrochloride 50 mg

*non-steroidal anti-inflammatory drug

Purpose

Pain reliever

Nighttime sleep-aid

Uses

• For relief of occasional sleeplessness when associated with minor aches and pains.
• Helps you fall asleep.

Warnings

Reye's syndrome:  Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert:  Salicylates (NSAIDs) may cause a severe allergic reaction which may include:

• hives
• skin reddening
• rash
• facial swelling
• shock
• asthma (wheezing)

Stomach bleeding warning:

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

• are age 60 or older
• have had stomach ulcers or bleeding problems
• take blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed

Do not use

• if you have ever had an allergic reaction to salicylates (including aspirin) or any other pain reliever/fever reducer
• unless you have time for a full night's sleep
• in children under 12 years of age
• with any other product containing diphenhydramine, even one used on skin
• if you have sleeplessness without pain

Ask a doctor before use if

• stomach bleeding warning applies to you
• you have a history of stomach problems such as heartburn, upset stomach, stomach pain, or ulcers
• you have high blood pressure, heart disease, liver cirrhosis or kidney disease
• you are taking a diurectic
• you have a breathing problem such as emphysema or chronic bronchitis
• you have asthma
• you have glaucoma
• you have trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers, or any other sleep-aid
• under a doctor's care for any continuing medical illness
• taking a prescription drug for diabetes, gout or arthritis

When using this product

• drowsiness will occur
• avoid alcoholic drinks
• do not drive a motor vehicle or operate machinery
• take with food or milk if stomach upset occurs

Stop use and ask a doctor if

• an allergic reaction occurs.  Seek medical help right away.
• you experience any of the following signs of stomach bleeding:
• feel faint
• have stomach pain that does not get better
• vomit blood
• have bloody or black stools
• symptoms do not improve
• pain gets worse or lasts more than 10 days  
• sleeplessness persists continuously for more than 2 weeks.  Insomnia may be a symptom of a serious underlying medical illness.
• ringing in the ears or loss of hearing occurs
• redness or swelling is present in the painful area
• fever gets worse or lasts more than 3 days
• any new symptoms appear 

If pregnant or breast-feeding, ask a health professional before use.  It is especially important not to use salicylates (NSAIDs) during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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 directed
• Adults and children 12 years of age and over:  Take 1 (57 mL) bottle at bedtime, if needed, or directed by a doctor.
• Do not take more than 1 (57 mL) bottle in 24 hours.
• Children under 12 years of age:  Do not use.

Other Information

• each dose contains 27 mg of sodium
• read all product information before using
• store at room temperature 59°-86°F (15°-30°C)
• avoid excessive heat and humidy
• tamper evident:  do not use if neckband on bottle cap is broken or missing

Inactive Ingredients

Artificial Flavor, Edetate Disodium, Glycerin, Maltitol, Purified Water, Sodium Citrate, Sorbitol

Questions? Comments?

Call 1-888-535-0305

SPL UNCLASSIFIED SECTION

VanaPain ®PM

NDC # 58809-444-60

www.vanapain.com

PRINCIPAL DISPLAY PANEL - 57mL Bottle Label

ONE SHOT

PM RELIEF

GLUTEN FREE

SUGAR FREE

TWIST TO OPEN

Do not use if neckband is broken or missing

NDC # 58809-444-60

VanaPain ®PM

CHOLINE SALICYLATE 870mg (NSAID) - Pain Reliver

DIPHENHYDRAMINE HCl 50mg - Nighttime Sleep Aid

Nighttime Pain Relief

Nighttime Sleep Aid

• Headache
• Backache
• Muscle Aches
• Minor Arthritis Pain
• Menstrual Cramps

Works Liquid Fast!

NON-HABIT FORMING

Great Tasting Strawberry Flavor!

NET WT:  1.93 OZ. (57ML)

Directions:

• Do not take more than directed.
• Adults and children 12 years of age and over:  take 1 (57mL) bottle at bedtime.
• Do not take more than 1 (57mL) bottles in 24 hours.
• Children under 12 years of age:  Do not use.

PATENT PENDING



INGREDIENTS AND APPEARANCE

VANAPAIN PM 
choline salicylate, diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58809-444
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHOLINE SALICYLATE (UNII: KD510K1IQW) (SALICYLIC ACID - UNII:O414PZ4LPZ)	CHOLINE SALICYLATE	870 mg  in 57 mL
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg  in 57 mL

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
MALTITOL (UNII: D65DG142WK)
WATER (UNII: 059QF0KO0R)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58809-444-60	57 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	10/28/2013

Labeler - GM Pharmaceuticals, Inc. (793000860)

Establishment
Name	Address	ID/FEI	Business Operations
Woodfield Pharmaceutical, LLC		079398730	manufacture(58809-444)