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

----------

Quality Choice 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:

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

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, occasionally, rapid heart beat.

Do not use

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

Ask a doctor before use if

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

  • an allergic reaction occurs. Seek medical help right away.
  • 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
  • ringing in the ears or a loss of hearing occurs
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in 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 accidental overdose, get medical help or contact a Poison Control Center right away. Prompt 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?

1-800-426-9391

Principal Display Panel

NDC 63868-485-01

QC®
QUALITY
CHOICE

Compare to the
active ingredients
in EXCEDRIN®
EXTRA STRENGTH

Headache Relief
Extra Strength
Acetaminophen, Aspirin (NSAID) and Caffeine
Pain Reliever | Pain Reliever Aid

100 Coated Tablets

Actual Size

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

This product is not manufactured or distributed by GSK
Consumer Healthcare SARL, owner of the registered trademark
Excedrin® Extra Strength.             50844      REV1121G15912

SATISFACTION
100% QC
GUARANTEED

Distributed by CDMA, Inc.
43157 W Nine Mile
Novi, MI 48375
www.qualitychoice.com
Questions: 800-935-2362

Quality Choice 44-159B

Quality Choice 44-159B

HEADACHE RELIEF  EXTRA STRENGTH
acetaminophen, aspirin and caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-485
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
STARCH, CORN (UNII: O8232NY3SJ)  
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE, UNSPECIFIED (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
ShapeROUNDSize11mm
FlavorImprint Code 44;159
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-485-241 in 1 CARTON11/17/1992
124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:63868-485-501 in 1 CARTON11/17/1992
250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:63868-485-011 in 1 CARTON11/17/1992
3100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:63868-485-021 in 1 CARTON11/17/199206/15/2019
4200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01311/17/1992
Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(63868-485)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(63868-485)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(63868-485)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(63868-485)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.117025878manufacture(63868-485)

Revised: 7/2023
Document Id: 7eee713e-7971-4c60-a606-6c7b00e07bcf
Set id: 4005f8dd-3050-4590-8703-6997444e8df3
Version: 28
Effective Time: 20230722
 
CHAIN DRUG MARKETING ASSOCIATION INC