APINOPHEN EXTRA STRENGTH- acetaminophen tablet 
A P J Laboratories Limited

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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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

LACTOSE MONOHYDRATE

STARCH, CORN

GELATIN

METHYLPARABEN

PROPYLPARABEN

MAGNESIUM STEARATE

TALC

SODIUM STARCH GLYCOLATE TYPE A POTATO

SILICON DIOXIDE

productEnter section text here

APINOPHEN  EXTRA STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:46084-061
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE10 mg
STARCH, CORN17 mg
GELATIN2 mg
METHYLPARABEN10 mg
PROPYLPARABEN1 mg
MAGNESIUM STEARATE10 mg
TALC10 mg
SODIUM STARCH GLYCOLATE TYPE A POTATO20 mg
SILICON DIOXIDE1 mg
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize13mm
FlavorImprint Code 500mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46084-061-25500 in 1 BLISTER PACK
2NDC:46084-061-24250 in 1 BLISTER PACK
3NDC:46084-061-23120 in 1 BLISTER PACK
4NDC:46084-061-2260 in 1 BLISTER PACK
5NDC:46084-061-112 in 1 BLISTER PACK
6NDC:46084-061-26100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/01/2013
Labeler - A P J Laboratories Limited (677378339)
Registrant - A P J Laboratories Limited (677378339)
Establishment
NameAddressID/FEIBusiness Operations
A P J Laboratories Limited677378339manufacture(46084-061)

Revised: 1/2014
Document Id: 5d9790ab-2120-4b04-a87c-d27e1e0640a2
Set id: c6ee8b69-c791-4ed0-a2bb-44a229dbcb0d
Version: 2
Effective Time: 20140102
 
A P J Laboratories Limited