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Vanapain PM

Medically reviewed on September 3, 2018

Dosage form: liquid
Ingredients: CHOLINE SALICYLATE 870mg in 57mL, DIPHENHYDRAMINE HYDROCHLORIDE 50mg in 57mL
Labeler: GM Pharmaceuticals, Inc.
NDC Code: 58809-444

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 ®PM

Drug Facts

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

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



VANAPAIN PM 
choline salicylate, diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-444
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHOLINE SALICYLATE (SALICYLIC ACID) CHOLINE SALICYLATE870 mg  in 57 mL
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE50 mg  in 57 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM 
GLYCERIN 
MALTITOL 
WATER 
TRISODIUM CITRATE DIHYDRATE 
SORBITOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:58809-444-6057 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34310/28/2013
Labeler - GM Pharmaceuticals, Inc. (793000860)
Establishment
NameAddressID/FEIOperations
Woodfield Pharmaceutical, LLC079398730manufacture(58809-444)

 
GM Pharmaceuticals, Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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