PAIN RELIEF- acetaminophen tablet, coated 
CHAIN DRUG CONSORTIUM

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1098-PRV-2020-0823

Drug Facts

Active ingredient (in each caplet)

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 caplets every 6 hours while symptoms last
  • swallow whole – do not crush, chew, or dissolve
  • do not take more than 6 caplets 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

acesulfame potassium, flavor, hypromellose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

1-844-705-4384

PRINCIPAL DISPLAY PANEL

Premier Value®

COMPARE TO THE ACTIVE INGREDIENT IN TYLENOL® EXTRA STRENGTH COOL CAPLETS†

EXTRA STRENGTH

Pain Relief

FOR ADULTS

ACETAMINOPHEN • COOL CAPLETS

PAIN RELIEVER/FEVER REDUCER

Instant Cooling Sensation

50 CAPLETS, 500 MG EACH

image description

PAIN RELIEF 
acetaminophen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-503
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize17mm
FlavorMINTImprint Code AAA;1098
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-503-021 in 1 CARTON05/01/201106/30/2024
150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:68016-503-031 in 1 CARTON05/01/201106/30/2024
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 DrugM01305/01/201106/30/2024
Labeler - CHAIN DRUG CONSORTIUM (101668460)

Revised: 10/2023
Document Id: 08f37d93-37ff-67f4-e063-6394a90a81d3
Set id: 770b437f-605b-4b16-8f46-acd2ead1c40d
Version: 4
Effective Time: 20231030
 
CHAIN DRUG CONSORTIUM