PAIN RELIEF  EXTRA STRENGTH- acetaminophen tablet 
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.

----------

TCR - 1003 - 2019-1016

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

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 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.

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.

Directions

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 use for more than 10 days unless directed by a doctor
children under 12 years
  • ask a doctor

Other information

Inactive ingredients

povidone, pregelatinized starch, sodium starch glycolate, stearic acid

PRINCIPAL DISPLAY PANEL

NDC 36800-905-02

TopCare® Health™

Extra Strength

Pain Relief

Acetaminophen 500 mg

Pain Reliever • Fever Reducer

For Adults

Pharmacists Recommend

60 Tablets

image description

PAIN RELIEF   EXTRA STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-905
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize12mm
FlavorImprint Code M2A4;57344
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-905-021 in 1 CARTON08/30/2011
160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:36800-905-041 in 1 CARTON08/30/2011
2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/30/2011
Labeler - TopCo Associates LLC (006935977)

Revised: 11/2021
Document Id: d0d6d527-c26f-0646-e053-2995a90abf86
Set id: bdb01b3e-ad34-4003-9b9a-e83a2c0e90bb
Version: 3
Effective Time: 20211115
 
TopCo Associates LLC