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Pain Free

Dosage form: tablet
Ingredients: ACETAMINOPHEN 1101, ASPIRIN 1621, CAFFEINE 32.41, SALICYLAMIDE 1521
Labeler: Afassco Inc.
NDC Code: 51532-0242

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 (In Each Tablet)

Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg

Pain reliever, Stimulant

Uses: For the temporary relief of pain from:

• headaches • colds • muscular aches

• menstrual cramps • toothaches

• minor arthritic pain • backaches

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.

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 non-prescription), or have 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 stomach bleeding. The chance is higher if you have had stomach ulcers or bleeding problems, take a blood thinning (anticoagulant) or steroid drug, are age 60 or older, have 3 or more alcoholic drinks every day while using this product, take with other drugs containing an NSAID, or take more or for a longer time than directed.

If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children.

Directions:

Adults and children: (12 years and older) Take 1 to 2 tablets with a full glass of water every 4 hours as needed. Do not exceed 6

tablets in 24 hours, or as directed by doctor.

Children: (under 12 years) Do not give to children under 12 years of age

SEE ORIGINAL BOX FOR COMPLETE PRODUCT INFORMATION

PAIN FREE 
acetaminophen, aspirin, caffeine, salicylamide tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51532-0242
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN110 
ASPIRIN (ASPIRIN) ASPIRIN162 
CAFFEINE (CAFFEINE) CAFFEINE32.4 
SALICYLAMIDE (SALICYLAMIDE) SALICYLAMIDE152 
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
MAGNESIUM STEARATE 
FD&C YELLOW NO. 6 
STEARIC ACID 
MICROCRYSTALLINE CELLULOSE 
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize11mm
FlavorImprint CodeFR2
Contains    
Packaging
#Item CodePackage Description
1NDC:51532-0242-22 TABLET in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34310/25/2016
Labeler - Afassco Inc. (609982723)

Revised: 11/2016
 
Afassco Inc.

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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