pain reliever by P & L Development, LLC Drug Facts

pain reliever by

Drug Labeling and Warnings

pain reliever by is a Otc medication manufactured, distributed, or labeled by P & L Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PAIN RELIEVER EXTRA STRENGTH- acetaminophen tablet 
P & L Development, 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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Drug Facts

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
    • headache
    • the common cold
    • backache 
    • minor pain of arthritis
    • toothache
    • muscular aches
    • premenstrual and menstrual cramps
  • temporarily reduces fever

Warnings

Liver warning:  This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 8 tablets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks ever day while using this product

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.

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

  • do not take more than directed (see Overdose warning)
  • adults and children 12 years and over:
    • take 2 tablets every 4 to 6 hours while symptoms last
    • do not take more than 8 tablets in 24 hours
    • do not take for more than 10 days unless directed by a doctor
  • children under 12 years: do not use

Other information

  • store at controlled room temperature 15°-30°C (59°-86°F)

Inactive ingredients

povidone, pregelatinized starch, sodium starch glycolate*, stearic acid

*may contain this ingredient

Questions or comments?

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

Principal Display Panel

†Compare to the active ingredient in Extra Strength TYLENOL®

Extra Strength

Pain Reliever

ACETAMINOPHEN 500 mg

Pain Reliever

Fever Reducer

Contains No Aspirin

TABLETS

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

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY 11590

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Product Label

Acetaminophen 500 mg

PL Developments Extra Strength Pain Reliever Tablet

PAIN RELIEVER  EXTRA STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 59726-016
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize12mm
FlavorImprint Code TCL;252
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 59726-016-401 in 1 BOX08/15/201112/31/2019
140 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC: 59726-016-1010 in 1 VIAL; Type 0: Not a Combination Product08/15/201112/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34308/15/201112/31/2019
Labeler - P & L Development, LLC (800014821)

Revised: 12/2018
Document Id: 90fc07b0-7901-47da-81b1-87f14b075e9a
Set id: 80b6de14-b003-4567-b03a-f710804fd4e7
Version: 3
Effective Time: 20181220