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Pain Relief Maximum Strength

Medically reviewed on October 16, 2017

Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 250mg, ASPIRIN 250mg, CAFFEINE 65mg
Labeler: Select Corporation
NDC Code: 52904-468

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.

Drug Facts

Active Ingredients

Acetaminophen 250 mg
Aspirin 250 mg
Caffeine 65 mg



Pain Reliever, Fever Reducer

Directions: Adults and children 12 years of age and older: 2 tablets as
needed for pain every 6 hours. Do not exceed 8 tablets in 24 hours or as
directed by a doctor. Children under 12 years: Consult a doctor

Uses: temporarily relieves minor aches and pains associated with:
• backache • headaches • colds • toothache • minor arthritis pain
• muscular aches

Warnings: Reye's syndrome:
Children and teenagers should not use this medicine for chicken pox or
flu symptoms before a doctor is consulted about Reye's syndrome, a
rare but serious illness reported to be associated with aspirin. Allergy
Alert-Do not use: • if you are allergic to aspirin or any other salicylate •
If you have ever had an allergic reaction to any other pain
reliever/fever reducer Liver Warning: This product contains
acetaminophen. Severe liver damage may occur if you take: • more
than 8 tablets in 24 hours • with other drugs containing acetaminophen
(prescription or nonprescription). Ask a doctor or pharmacist before
using with other drugs if you are not sure. • 3 or more alcoholic drinks
every day while using this product Stomach Bleeding Warning: This
product contains nonsteroidal antiinflammatory dugs (NSAIDs), which
may cause 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 an
NSAID (aspirin, ibuprofen, naproxen, or others). • Take more or for a
longer time than directed Do not use: • if you are allergic to aspirin
• with any other pain reliever/fever reducer • if you have
ever had an allergic reaction to any other pain
reliever/fever reducer • for pain for more than 10 days or for
fever for more than 3 days unless directed by a doctor • with
any other product containing acetaminophen Ask doctor
before using if you have: • asthma • stomach problems (such as
heartburn, upset stomach or stomach pain) • gastric ulcers • bleeding
problems Ask a doctor or pharmacist before use if you are taking a
prescription drug for: • anticoagulation (thinning of blood) • diabetes •
gout • arthritis. When using this product do not exceed recommended dose.
Stop use and ask a doctor if: • ringing in the ears or loss of hearing occurs
• pain or fever persists or gets worse • new symptoms occur • redness or
swelling is present

If pregnant or breast-feeding baby, ask a health
professional before use. IT IS ESPECIALLY IMPORTANT NOT TO USE
ASPIRIN DURING THE LAST 3 MONTHS OF PREGNANCY UNLESS
SPECIFICALLY 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.

IInactive Ingredients: Hydroxypropyl Methylcellulose, Maltodextrin,
Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Sodium Starch
Glycolate, Starch, Stearic Acid, Titanium Dioxide

MM1

PAIN RELIEF MAXIMUM STRENGTH  
acetaminophen,aspirin,caffeine tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52904-468
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
POVIDONE K29/32 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
CELLULOSE, MICROCRYSTALLINE 
STEARIC ACID 
MALTODEXTRIN 
STARCH, CORN 
POLYETHYLENE GLYCOL 300 
TITANIUM DIOXIDE 
Product Characteristics
Colorwhite (snow white) Scoreno score
ShapeROUND (FR9) Size12mm
FlavorImprint CodeFR9
Contains    
Packaging
#Item CodePackage Description
1NDC:52904-468-022 TABLET, COATED (TABLET) in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34310/15/2012
Labeler - Select Corporation (053805599)

 
Select Corporation

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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