PAIN RELIEVER EXTRA STRENGTH- acetaminophen tablet, coated
Topco Associates, LLC

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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TopCare 44-531-Reliever

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:
- backache
- muscular aches
- headache
- the common cold
- toothache
- minor pain of arthritis
- 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 in 24 hours, which is the maximum daily amount
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:

blisters
rash
skin reddening

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

Do not use

with any other drug containing acetaminophen (prescription or nonprescription). 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.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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
adults and children 12 years and over
- take 2 tablets every 6 hours while symptoms last
- do not take more than 6 tablets 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
use by expiration date on package

Inactive ingredients

corn starch, D&C yellow #10 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Principal Display Panel

TopCare®

NDC 36800-531-06

EXTRA STRENGTH
Pain
Reliever
ACETAMINOPHEN
PAIN RELIEVER / FEVER REDUCER

• Easy to swallow
• Contains no aspirin
• Sweet coated

ACTUAL
SIZE

200 TABLETS - 500 mg EACH

COMPARE TO
EXTRA STRENGTH
TYLENOL®
active ingredient*

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

QUALITY GUARANTEED

DISTRIBUTED BY TOPCO ASSOCIATES LLC,
ELK GROVE VILLIAGE, IL 60007
©TOPCO LNK1216
QUESTIONS? 1-888-423-0139
topcare@topco.com
www.topcarebrand.com

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol®.

50844 ORG081653106

TopCare 44-531

PAIN RELIEVER EXTRA STRENGTH
acetaminophen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-531
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
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C RED NO. 40 (UNII: WZB9127XOA)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POVIDONE (UNII: FZ989GH94E)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TALC (UNII: 7SEV7J4R1U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	44;531
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:36800-531-06	200 in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2005	02/18/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part343	12/11/2005	02/18/2022

Labeler - Topco Associates, LLC (006935977)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	MANUFACTURE(36800-531)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(36800-531)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	PACK(36800-531)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	PACK(36800-531)

Revised: 4/2019

Document Id: 49cedc93-aa86-4003-be9e-ef340f263087

Set id: 02c25cdd-f4fd-414e-9e79-dd70488fbb96

Version: 3

Effective Time: 20190424

Topco Associates, LLC