PAIN RELIEF EXTRA STRENGTH- acetaminophen tablet 
P & L Development, LLC

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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:

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

If a skin reaction occurs, stop use and seek a 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Other information

Inactive ingredients

corn starch, croscarmellose sodium*, hypromellose*, lactose monohydrate*, magnesium stearate*,maltodextrin*, medium-chain triglycerides*, mineral oil*, polydextrose*, polyethylene glycol*, polyvinyl alcohol*, povidone, purified water*, sodium starch glycolate, stearic acid*, talc*, titanium dioxide

*contains one or more of these ingredients

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Tylenol® Extra Strength

Extra Strength

Pain Reliever

Acetaminophen, 500 mg

Pain Reliever/Fever Reducer

Caplets

†This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol® Extra Strength.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY 11590

Product Label

Acetaminophen 500 mg

READYinCASE Pain Reliever

PAIN RELIEF  EXTRA STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-494
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
WATER (UNII: 059QF0KO0R)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code TCL341;AV;0821;P500
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59726-494-241 in 1 BOX03/31/2016
124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:59726-494-051 in 1 BOX03/31/2016
2500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:59726-494-10100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/31/2016
4NDC:59726-494-501 in 1 BOX03/31/2016
450 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01303/31/2016
Labeler - P & L Development, LLC (800014821)

Revised: 4/2024
Document Id: a39c8dbb-7f2c-4ac3-bc03-581e56636f77
Set id: 59eb14a5-40b0-4331-beb5-7166e6cdf411
Version: 9
Effective Time: 20240416
 
P & L Development, LLC