APINOPHEN EXTRA STRENGTH- acetaminophen tablet

APINOPHEN by

Drug Labeling and Warnings

APINOPHEN by is a Otc medication manufactured, distributed, or labeled by A P J Laboratories Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

active ingredient

Acetaminophen 500 mg

purpose

Pain reliever/fever reducer

keep out of reach of children

Overdose warning:

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

uses

temporarily relieves minor aches and pains due to:

the common cold
headache
backache
minor pain of arthritis
toothache
muscular aches
premenstrual and menstrual cramps
temporarily reduces fever

warning

Liver warning:

This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3,000 mg) in 24 hours. Severe liver damage may occur if you take

more than 4,000 mg of acetaminophen in 24 hours

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product

directions

do not take more than directed (see overdose warning)

adults and children 12 years and over: take 2 caplets every 6 hours while symptoms last
swallow whole – do not crush, chew, or dissolve
do not take more than 6 caplets in 24 hours, unless directed by a doctor
do not use for more than 10 days unless directed by a doctor

children under 12 years : ask a doctor

INACTIVE INGREDIENT

LACTOSE MONOHYDRATE

INACTIVE INGREDIENT

STARCH, CORN

INACTIVE INGREDIENT

GELATIN

INACTIVE INGREDIENT

METHYLPARABEN

INACTIVE INGREDIENT

PROPYLPARABEN

INACTIVE INGREDIENT

MAGNESIUM STEARATE

INACTIVE INGREDIENT

TALC

INACTIVE INGREDIENT

SODIUM STARCH GLYCOLATE TYPE A POTATO

INACTIVE INGREDIENT

SILICON DIOXIDE

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

APINOPHEN  EXTRA STRENGTH
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46084-061
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)	10 mg
STARCH, CORN (UNII: O8232NY3SJ)	17 mg
GELATIN (UNII: 2G86QN327L)	2 mg
METHYLPARABEN (UNII: A2I8C7HI9T)	10 mg
PROPYLPARABEN (UNII: Z8IX2SC1OH)	1 mg
MAGNESIUM STEARATE (UNII: 70097M6I30)	10 mg
TALC (UNII: 7SEV7J4R1U)	10 mg
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)	20 mg
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)	1 mg

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	13mm
Flavor		Imprint Code	500mg
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46084-061-25	500 in 1 BLISTER PACK
2	NDC: 46084-061-24	250 in 1 BLISTER PACK
3	NDC: 46084-061-23	120 in 1 BLISTER PACK
4	NDC: 46084-061-22	60 in 1 BLISTER PACK
5	NDC: 46084-061-11	2 in 1 BLISTER PACK
6	NDC: 46084-061-26	100 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	03/01/2013

Labeler - A P J Laboratories Limited (677378339)

Registrant - A P J Laboratories Limited (677378339)

Establishment
Name	Address	ID/FEI	Business Operations
A P J Laboratories Limited		677378339	manufacture(46084-061)