PAIN RELIEVER PLUS- acetaminophen, aspirin and caffeine tablet, film coated 
Avera McKennan Hospital

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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Major 44-159B

Active ingredients (in each tablet)

Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever
Pain reliever
Pain reliever aid

Uses

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: Aspirin may cause a severe allergic reaction, which may include:

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

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

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionaly, rapid heartbeat.

Do not use

  • if you ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer
  • with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if

  • you have liver disease
  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis or kidney disease
  • you have asthma
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are

  • taking a prescription drug for diabetes, gout, or arthritis
  • taking any other drug or are under a doctor's care for any serious condition

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • have bloody or black stools
    • vomit blood
    • have stomach pain that does not get better
  • an allergic reaction occurs. Seek medical help right away.
  • any new symptoms appear
  • ringing in the ears or loss of hearing occurs
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • painful area is red or swollen

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use aspirin 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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Other information

Inactive ingredients

corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

(800) 616-2471

Principal Display Panel

Acetaminophen/Aspirin/Caffeine 250/250/65 mg tablet label

PAIN RELIEVER PLUS 
acetaminophen, aspirin and caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69189-5135(NDC:0904-5135)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE (UNII: 68401960MK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONES (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize13mm
FlavorImprint Code 44;159
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69189-5135-11 in 1 DOSE PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34304/14/2015
Labeler - Avera McKennan Hospital (068647668)
Establishment
NameAddressID/FEIBusiness Operations
Avera McKennan Hospital068647668relabel(69189-5135) , repack(69189-5135)

Revised: 1/2016
Document Id: 139fc3b0-ecea-4e64-b71d-f74e721e8dd9
Set id: aa13aecd-0d8a-438d-a83b-af392da48f58
Version: 1
Effective Time: 20160105
 
Avera McKennan Hospital