VANAPAIN- choline salicylate, caffeine liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CHOLINE SALICYLATE (UNII: KD510K1IQW) (SALICYLIC ACID - UNII:O414PZ4LPZ), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)
Available from:
GM Pharmaceuticals, Inc.
INN (International Name):
CHOLINE SALICYLATE
Composition:
CHOLINE SALICYLATE 870 mg in 57 mL
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Temporarily relieves minor aches anc pains due to: - headache - minor arthritis pain - muscle aches - menstrual cramps - backache - temporarily reduces fever
Authorization status:
OTC monograph not final
Authorization number:
58809-123-60

VANAPAIN- choline salicylate, caffeine liquid

GM Pharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

VanaPain

Drug Facts

Active ingredients

(per 57 mL)

Caffeine 65 mg

Choline Salicylate (NSAID*)

*non-steroidal anti-inflammatory drug

Purpose

Pain reliever aid

Pain reliever / fever reducer

Us es

Temporarily relieves minor aches anc pains due to:

headache

minor arthritis pain

muscle aches

menstrual cramps

backache

temporarily reduces fever

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

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 ever had an allergic reaction to salicylates (including aspirin) or any other pain

reliever/ fever reducer.

Ask a doctor before use if

stomach bleeding warning applies to you

you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

you are taking a diuretic

you have a history of stomach problems such as heartburn, upset stomach, stomach pain, or ulcers

you have asthma

Ask a doctor or pharmacist before use if

under a doctor's care for any serious condition

taking a prescription drug for diabetes, gout, or arthritis

When using this product

limit the use of caffeine containing medications, foods, or beverages because too much caffeine

may cause nervousness, irritability, sleeplessness, and occasionally, rapid heart beat

the recommended dose of this product contains about as much caffeine as a cup of coffee

take with food or milk if stomach upset occurs

Stop use and ask a doctor if

you experience any of the following signs of stomach bleeding:

feel faint

vomit blood

have bloody or black stools

have stomach pain that does not get better

symptoms do not improve

pain gets worse or lasts more than 10 days

ringing in the ears or loss of hearing occurs

redness or swelling is present

any new symptoms appear

fever gets worse or lasts more than 3 days

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

Adults and children 12 years of age and over: Take 1 (57 mL) bottle every 6 hours, while symptoms

persist.

Do not take more than 4 (57 mL) bottles in 24 hours unless directed by a doctor.

Children under 12 years of age: ask a doctor

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 Dihydrate,

Sorbitol

Questions? Comments?

Call 1-888-535-0305

VanaPain

NDC # 58809-123-60

www.vanapain.com

PRINCIPAL DISPLAY PANEL - 57mL Bottle Label

ONE SHOT PAIN RELIEF

GLUTEN FREE

SUGAR FREE

TWIST TO OPEN

Do not use if neckband is broken or missing

NDC # 58809-123-60

VanaPain

CHOLINE SALICYLATE 870mg (NSAID) - Pain Reliver / Fever Reducer

CAFFEINE 65mg - Pain Reliever Aid

Vanish Pain With One Shot

Stops Pain Up to 6 Hours

Headache

Backache

Muscle Aches

Minor Arthritis Pain

Menstrual Cramps

Works Liquid Fast!

Great Tasting Strawberry Flavor!

NET WT: 1.93 OZ. (57ML)

Directions:

Adults and children 12 years of age and over: take 1 (57mL) bottle every 6 hours, while symptoms

persist.

Do not take more than 4 (57mL) bottles in 24 hours unless directed by a doctor.

®

Children under 12 years of age: Ask a doctor.

VANAPAIN

choline salicylate, caffeine liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:58 8 0 9 -123

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CHO LINE SALICYLATE (UNII: KD510 K1IQW) (SALICYLIC ACID - UNII:O414PZ4LPZ)

CHOLINE SALICYLATE

8 70 mg in 57 mL

GM Pharmaceuticals, Inc.

CAFFEINE (UNII: 3G6 A5W338 E) (CAFFEINE - UNII:3G6 A5W338 E)

CAFFEINE

6 5 mg in 57 mL

Inactive Ingredients

Ingredient Name

Stre ng th

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

GLYCERIN (UNII: PDC6 A3C0 OX)

MALTITO L (UNII: D6 5DG142WK)

WATER (UNII: 0 59 QF0 KO0 R)

TRISO DIUM CITRATE DIHYDRATE (UNII: B22547B9 5K)

SO RBITO L (UNII: 50 6 T6 0 A25R)

Product Characteristics

Color

S core

S hap e

S iz e

Flavor

STRAWBERRY

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:58 8 0 9 -123-

57 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt343

0 7/22/20 13

Labeler -

GM Pharmaceuticals, Inc. (793000860)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Wo o dfield Pharmaceutical, LLC

0 79 39 8 730

ma nufa c ture (58 8 0 9 -123)

Revised: 6/2015

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