EXTRA STRENGTH HEADACHE RELIEF- acetaminophen, aspirin and caffeine tablet, film coated 
CHAIN DRUG MARKETING ASSOCIATION 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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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

  • temporarily relieves minor aches and pains due to:
  • headache
  • a cold
  • arthritis
  • muscular aches
  • sinusitis
  • toothache
  • premenstrual and menstrual cramps

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:

  • hives
  • facial swelling
  • shock
  • asthma (wheezing)

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

  • more than 8 tablets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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 a 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

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, occasionally, rapid heartbeat.

Do not use

  • if you ever had an allergic reaction to 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

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 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

  • do not use more than directed
  • drink a full glass of water with each dose
  • adults and children 12 years and over
  • take 2 tablets every 6 hours
  • do not take more than 8 tablets in 24 hours
  • children under 12 years: do not use unless directed by a doctor

Other information

  • store at controlled room temperature 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

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

Principal Display Panel

QC
QUALITY
CHOICE®

NDC 63868-485-02

Compare to the active ingredients in EXCEDRIN® EXTRA STRENGTH†

HEADACHE RELIEF
EXTRA STRENGTH
Acetaminophen, Aspirin (NSAID) and Caffeine
Pain Reliever/Pain Reliever Aid

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

†This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Excedrin® Extra Strength.
50844     ORG101115906

Quality Choice 44-159A

Quality Choice 44-159A

EXTRA STRENGTH HEADACHE RELIEF 
acetaminophen, aspirin and caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-485
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN250 mg
ASPIRIN (ASPIRIN) ASPIRIN250 mg
CAFFEINE (CAFFEINE) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE 
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POVIDONES 
PROPYLENE GLYCOL 
SODIUM LAURYL SULFATE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize13mm
FlavorImprint Code 44;159
Contains    
Packaging
#Item CodePackage Description
1NDC:63868-485-011 in 1 CARTON
1100 in 1 BOTTLE, PLASTIC
2NDC:63868-485-021 in 1 CARTON
2200 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34311/17/1992
Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(63868-485)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(63868-485)

Revised: 07/2013
Document Id: 823ceb14-d730-4e7f-9894-9923d99e4f04
Set id: 4005f8dd-3050-4590-8703-6997444e8df3
Version: 10
Effective Time: 20130731
 
CHAIN DRUG MARKETING ASSOCIATION INC