PAIN FREE PLUS- acetaminophen, aspirin, caffeine tablet

Pain Free Plus by

Drug Labeling and Warnings

Pain Free Plus by is a Otc medication manufactured, distributed, or labeled by Afassco Inc., ULTRAtab Laboratories, Inc., Ultra Seal Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Acetaminophen 250mg, Aspirin 250mg, Caffeine 65mg

PURPOSE

Pin reliever, Stimulant

INDICATIONS & USAGE

Uses: For the temporary relief of pain from:

headaches muscular aches

menstrual cramps toothaches

minor arthritic pain colds

WARNINGS

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

Keep out of reach of children.

DOSAGE & ADMINISTRATION

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.

INACTIVE INGREDIENT

SEE ORIGINAL BOX FOR COMPLETE PRODUCT INFORMATION

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

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)