Pain Relief: Package Insert and Label Information

PAIN RELIEF- acetaminophen tablet, film 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.

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:

    • toothache
    • headache

    • the common cold
    • backache

    • muscular aches

    • 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 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:

  • 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 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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, D&C red #27 aluminum lake, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate*, stearic acid, sucralose, talc, titanium dioxide

*may contain this ingredient

Questions or comments?

1-888-423-0139

Principal display panel

+TopCare ®
health™

COMPARE TO
EXTRA STRENGTH TYLENOL®
ACTIVE INGREDIENT†

NDC 36800-991-15

EXTRA STRENGTH
Pain Relief
ACETAMINOPHEN 500 mg
PAIN RELIEVER • FEVER REDUCER

Contains no aspirin

50 TABLETS

actual size

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
© TOPCO LNKA0422
QUESTIONS? 1-888-423-0139
topcare@topco.com www.topcarebrand.com

Scan here for more information
or call 1-888-423-0139

QUALITY GUARANTEED

This TopCare® product is laboratory
tested to guarantee its highest quality.
Your total satisfaction is guaranteed.

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

†This product is not manufactured or distributed by
Johnson & Johnson Corporation, owner of the
registered trademark Extra Strength Tylenol®. 50844 ORG122053115

TopCare 44-531
(click image for full-size original)

TopCare 44-531

PAIN RELIEF acetaminophen tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-991
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
STARCH, CORN
D&C RED NO. 27 ALUMINUM LAKE
D&C YELLOW NO. 10 ALUMINUM LAKE
FD&C BLUE NO. 1 ALUMINUM LAKE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
STEARIC ACID
SUCRALOSE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color red Score no score
Shape ROUND Size 11mm
Flavor Imprint Code 44;531
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36800-991-15 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (36800-991-15)
2 NDC:36800-991-06 200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 01/30/2019
Labeler — Topco Associates, LLC (006935977)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 pack (36800-991)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 manufacture (36800-991)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867894 manufacture (36800-991)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 868734088 manufacture (36800-991)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 pack (36800-991)

Revised: 07/2022 Topco Associates, LLC

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