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 caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
    • headache
    • the common cold
    • backache 
    • minor arthritis pain 
    • 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 4,000 mg of acetaminophen in 24 hours
  • 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.
  • 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

  • do not take more than directed (see Overdose warning)
  • adults and children 12 years and over
    • take 2 caplets every 6 hours while symptoms last
    • do not take more than 6 caplets 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 between 20-25°C (68-77°F)

Inactive ingredients

corn starch*, crospovidone*, hypromellose, maltodextrin*, mineral oil*, polydextrose*, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid, talc*, titanium dioxide, triglycerides*

*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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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

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

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY  11590

Product Label

Acetaminophen 500 mg

ReadyInCase Extra Strength Pain Reliever Caplet

PAIN RELIEVER  EXTRA STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 59726-159
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)  
CROSPOVIDONE (UNII: 2S7830E561)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)  
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code TCL341;AV;0821
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 59726-159-241 in 1 BOX05/01/201412/31/2019
124 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 FINALpart34305/01/201412/31/2019
Labeler - P & L Development, LLC (800014821)

Revised: 12/2018
Document Id: c02edddb-2d61-4f71-90a6-ffb3ea195c65
Set id: 5b9a5bf2-94e2-4033-bfed-a240cd5c5cc5
Version: 2
Effective Time: 20181220
 
P & L Development, LLC