PLUSPHARMA EXTRA STRENGTH PAIN RELIEVER,FEVER REDUCER 500 MG- acetaminophen tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)

Available from:

direct rx

Administration route:

ORAL

Prescription type:

OTC DRUG

Authorization status:

OTC monograph not final

Patient Information leaflet

ACETAMINOPHEN TABLET
direct rx
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.
----------
PlusPHARMA
See New Warnings Information and Directions
Extra Strength
ACETAMINOPHEN 500 mg
PAIN RELIEVER FEVER REDUCER
CONTAINS NO ASPIRIN
Compare to the Active Ingredient in Extra Strength Tylenol®
This product is not manufactured or distributed by McNeil Consumer
Healthcare, owner of the registered
trademark Extra Strength Tylenol®
Revised: 7/2023
Document Id: 00edb965-211c-d896-e063-6294a90a86ad
34390-5
Set id: aa6cc288-ad0d-92e2-e053-2995a90a9e16
Version: 2
Effective Time: 20230720
direct rx

Summary of Product characteristics

PLUSPHARMA EXTRA STRENGTH PAIN RELIEVER,FEVER REDUCER 500 MG-
ACETAMINOPHEN TABLET
DIRECT RX
_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._
----------
PLUSPHARMA EXTRA STRENGTH PAIN RELIEVER,FEVER REDUCER 500 MG
PlusPHARMA
See New Warnings Information and Directions
Extra Strength
ACETAMINOPHEN 500 mg
PAIN RELIEVER FEVER REDUCER
CONTAINS NO ASPIRIN
Compare to the Active Ingredient in Extra Strength Tylenol®
This product is not manufactured or distributed by McNeil Consumer
Healthcare, owner
of the registered trademark Extra Strength Tylenol®
If you have any questions or comments, or to report an adverse event,
please contact
[phone].
Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic
Acid.
Do not use if imprinted safety seal under cap is broken or missing
Store at room temperature
PLUSPHARMA EXTRA STRENGTH PAIN RELIEVER,FEVER REDUCER
500 MG
acetaminophen tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:72189-120(NDC:51645-706)
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
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)
STARCH, CORN (UNII: O8232NY3SJ)
PRODUCT CHARACTERISTICS
COLOR
white
SCORE
2 pieces
SHAPE
ROUND
SIZE
12mm
FLAVOR
IMPRINT CODE
GPI;A5
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:72189-120-
50
50 in 1 BOTTLE; Type 0: Not a Combination
Product
07/14/2020
08/31/2023
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC monograph not
final
part343
07/14/2020
08/31/2023
LABELER -
direct rx (079254320)
REGISTRANT -
di