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.

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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

Uses

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 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 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.



Principal Display Panel - 57mL Bottle Label
VANAPAIN 
choline salicylate, caffeine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-123
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHOLINE SALICYLATE (UNII: KD510K1IQW) (SALICYLIC ACID - UNII:O414PZ4LPZ) CHOLINE SALICYLATE870 mg  in 57 mL
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg  in 57 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58809-123-6057 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/201812/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34307/22/201312/30/2020
Labeler - GM Pharmaceuticals, Inc. (793000860)
Establishment
NameAddressID/FEIBusiness Operations
Woodfield Pharmaceutical, LLC079398730manufacture(58809-123)

Revised: 1/2021
 
GM Pharmaceuticals, Inc.