PAIN FREE PLUS- acetaminophen, aspirin, caffeine tablet 
Afassco 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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Drug Facts

Acetaminophen 250mg, Aspirin 250mg, Caffeine 65mg

Pin reliever, Stimulant

Uses: For the temporary relief of pain from:

• headaches • muscular aches

• menstrual cramps • toothaches

• minor arthritic pain • colds

WARNING:

Reye's Syndrome Warning: 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)

• 3 or more alcoholic drinks every day while using this product.

Stomach Bleeding Warning: This product contains nonsteroidal antiinflammatory 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 • take more or for a longer time than directed.

Keep out of reach of children.

DIRECTIONS:

Adults: 2 tablets with a full glass of water every 6 hours as needed. Do not exceed 8 tablets in a 24 hour period.

Children under 12 years of age: Consult a doctor.

SEE ORIGINAL BOX FOR COMPLETE PRODUCT INFORMATION

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PAIN FREE PLUS 
acetaminophen, aspirin, caffeine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51532-0560
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STARCH, CORN (UNII: O8232NY3SJ)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color white Score no score
Shape ROUND Size 11mm
Flavor Imprint Code FR9
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51532-0560-2 2 in 1 PACKET; Type 0: Not a Combination Product 10/25/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 10/25/2016
Labeler - Afassco Inc. (609982723)
Registrant - ULTRAtab Laboratories, Inc. (151051757)
Establishment
Name Address ID/FEI Business Operations
ULTRAtab Laboratories, Inc. 151051757 manufacture(51532-0560)
Establishment
Name Address ID/FEI Business Operations
Ultra Seal Corporation 085752004 pack(51532-0560)

Revised: 9/2019
Document Id: 7f2110ff-0645-4106-8d8d-058bee3097aa
Set id: 9968232c-6039-4f4a-a51d-093c543192db
Version: 5
Effective Time: 20190921
 
Afassco Inc.