PLUSPHARMA EXTRA STRENGTH PAIN RELIEVER,FEVER REDUCER 500 MG- acetaminophen tablet
Gemini Pharmaceuticals, Inc. dba Plus Pharma

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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Acetaminophen 500 mg Caplet

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purposes
Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:
headache
muscular aches
backache
minor pain of arthritis
the common cold
toothache
premenstrual and menstrual cramps
temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. 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

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have liver disease.

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Stop use and ask a doctor if

pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
new symptoms occur
redness or swelling is present

These could be signs of a serious condition.

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

Keep out of reach of children.

Overdose warning: In the 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.

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
do not take more than 6 caplets in 24 hours unless directed by a doctor
do not take for more than 10 days unless directed by a doctor
children under 12 years: ask a doctor

Other information

store at room temperature in a dry place

Inactive ingredients Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions? If you have any questions or comments, or to report an adverse event, please contact (800) 795-9775.

Distributed By: Plus Pharma, Commack, NY 11725

Manufactured in a GMP facility in the USA

1000-COUNT

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

PlusPHARMA™

NDC 51645-705-10

See New Warnings Information

Extra Strength

ACETAMINOPHEN 500 mg

PAIN RELIEVER • FEVER REDUCER

CONTAINS NO ASPIRIN

Compare to the Active Ingredient in Extra Strength Tylenol®

Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye)

*Plus Pharma is not affiliated with the owner of the registered trademark Tylenol®

1000 CAPLETS • 500 mg each

51645-705-10

100-COUNT

PlusPHARMA™
NDC 51645-705-01
See New Warnings Information
Extra Strength
ACETAMINOPHEN 500 mg
PAIN RELIEVER • FEVER REDUCER
CONTAINS NO ASPIRIN
Compare to the Active Ingredient in Extra Strength Tylenol®
Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye)
*Plus Pharma is not affiliated with the owner of the registered trademark Tylenol®
100 CAPLETS • 500 mg each

51645-705-01

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51645-705
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	OVAL (white biconvex caplet)	Size	5mm
Flavor		Imprint Code	GPI;A5
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51645-705-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2006	05/31/2023
2	NDC:51645-705-06	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2006	12/31/2019
3	NDC:51645-705-10	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2006	05/31/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	03/27/2006	05/31/2023

Labeler - Gemini Pharmaceuticals, Inc. dba Plus Pharma (055942270)

Name	Address	ID/FEI	Business Operations
Establishment
Gemini Pharmaceuticals, Inc. dba Plus Pharma		055942270	manufacture(51645-705)

Revised: 9/2022

Document Id: e8f7b82d-94c5-ab64-e053-2995a90a5910

Set id: b6505efb-2cdb-4075-9efc-3131bbe5ed06

Version: 6

Effective Time: 20220918

Gemini Pharmaceuticals, Inc. dba Plus Pharma