OTC Medication Information: APINOPHEN EXTRA STRENGTH

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.

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

product
(click image for full-size original)

APINOPHEN EXTRA STRENGTH acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:46084-061
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE 10 mg
STARCH, CORN 17 mg
GELATIN 2 mg
METHYLPARABEN 10 mg
PROPYLPARABEN 1 mg
MAGNESIUM STEARATE 10 mg
TALC 10 mg
SODIUM STARCH GLYCOLATE TYPE A POTATO 20 mg
SILICON DIOXIDE 1 mg
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 13mm
Flavor Imprint Code 500mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46084-061-25 500 TABLET (TABLET) in 1 BLISTER PACK None
2 NDC:46084-061-24 250 TABLET (TABLET) in 1 BLISTER PACK None
3 NDC:46084-061-23 120 TABLET (TABLET) in 1 BLISTER PACK None
4 NDC:46084-061-22 60 TABLET (TABLET) in 1 BLISTER PACK None
5 NDC:46084-061-11 2 TABLET (TABLET) in 1 BLISTER PACK None
6 NDC:46084-061-26 100 TABLET in 1 BOTTLE None
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 Operations
A P J Laboratories Limited 677378339 manufacture (46084-061)

Revised: 01/2014 A P J Laboratories Limited

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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