PAIN FREE- acetaminophen, aspirin, caffeine, salicylamide tablet

Pain Free by

Drug Labeling and Warnings

Pain Free by is a Otc medication manufactured, distributed, or labeled by Afassco Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (In Each Tablet)

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

PURPOSE

Pain reliever, Stimulant

INDICATIONS & USAGE

Uses: For the temporary relief of pain from:

headaches colds muscular aches

menstrual cramps toothaches

minor arthritic pain backaches

WARNINGS

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.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

SEE ORIGINAL BOX FOR COMPLETE PRODUCT INFORMATION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN FREE 
acetaminophen, aspirin, caffeine, salicylamide tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51532-0242
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	110
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	162
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	32.4
SALICYLAMIDE (UNII: EM8BM710ZC) (SALICYLAMIDE - UNII:EM8BM710ZC)	SALICYLAMIDE	152

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
MAGNESIUM STEARATE (UNII: 70097M6I30)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
STEARIC ACID (UNII: 4ELV7Z65AP)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	FR2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51532-0242-2	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)