EXTRA STRENGTH HEADACHE RELIEF- acetaminophen, aspirin, caffeine tablet 
Meijer, Inc.

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EXTRA STRENGTH HEADACHE RELIEF

Drug Facts

Drug Facts

Active ingredients (in each caplet)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug

Purposes
Pain reliever
Pain reliever
Pain reliever aid

Uses
temporarily relieves minor aches and pains due to:
■ headache ■ a cold ■ arthritis ■ muscular aches
■ toothache ■ premenstrual & 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:Acetaminophen may cause severe skin reactions.
Symptoms may include: ■ skin reddening ■ blisters ■ rash
If a skin reaction occurs, stop use and seek medical help right
way.
Allergy alert:Aspirin may cause a severe allergic reaction which
may include: ■ hives ■ facial swelling ■ asthma (wheezing)
■ shock
Liver warning:This product contains acetaminophen. Severe
liver damage may occur if you take ■ more than 8 caplets 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 a nonsteroidal anti-inflammatory drug
(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
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.

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 are taking a diuretic
■ you have asthma

Ask a doctor or pharmacist before use if you are taking
■ a prescription drug for diabetes, gout, or arthritis
■ 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 ■ vomit blood ■ have bloody or black stools
■ have stomach pain that does not get better
■ ringing in the ears or loss of hearing occurs
■ painful area is red or swollen
■ pain gets worse or lasts for more than 10 days
■ fever gets worse or lasts for more than 3 days
■ any new symptoms appear
These could be signs of a serious condition

If pregnant or breast-feedingask 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 1(800)222-1222. 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 caplets
every 6 hours; not more than 8 caplets in 24 hours
■ children under 12 years: ask a doctor

Other information
■ store between 20º - 25º C (68º - 77º F)

Inactive ingredients
colloidal silicon dioxide, hypromellose, microcrystalline
cellulose, polyethylene glycol, povidone, pregelatinized starch,
stearic acid, talc

Questions or comments? 1-888-333-9792

PRINCIPAL DISPLAY PANEL

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EXTRA STRENGTH HEADACHE RELIEF 
acetaminophen, aspirin, caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79481-0062
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULE (capsule shaped, biconvex) Size18mm
FlavorImprint Code S53
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79481-0062-51 in 1 CARTON06/18/2024
150 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:79481-0062-11 in 1 CARTON06/18/2024
2100 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:79481-0062-32 in 1 CARTON06/18/2024
3NDC:79481-0062-2100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01306/18/2024
Labeler - Meijer, Inc. (006959555)

Revised: 6/2024
Document Id: 1b2fe368-dfb2-2c2f-e063-6294a90a7767
Set id: dbe06e36-2441-40bc-a747-db543dd65cad
Version: 1
Effective Time: 20240618
 
Meijer, Inc.