Extra Strength Pain Relief PM

Extra Strength Pain Relief PM by

Drug Labeling and Warnings

Extra Strength Pain Relief PM by is a Otc medication manufactured, distributed, or labeled by P and L Development of New York Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EXTRA STRENGTH PAIN RELIEF PM- acetaminophen, diphenhydramine hydrochloride capsule, liquid filled 
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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Extra Strength Pain Relief PM

Active ingredients (in each geltab)

Acetaminophen 500mg

Diphenhydramine HCl 25mg

Purpose

Pain Reliver

Nighttime sleep aid

Uses

for temporary relief of occasional headaches, minor aches and pains accompanying sleeplessness.

Warnings

Liver warning: This product contains acetaminophen severe liver damage may occur with this product if you take:

  • more than 2 geltabs in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drink every day while using this product

Keep out of reach of children

Keep out of reach of children

Directions

  • do not exceed recommended dose
  • adults and children 12 years of age and over: take 2 geltabs at bedtime. Do not take more than 2 geltabs in 24 hours
  • children under 12 years of age: do not use this adult product in children under 12 years of age. This will provide more than the recommended dose (overdose) and may cause liver damage.

Other Information

  • store at room temperature 15°-30°C (59°-86°F), avoid high humidity and excessive heat
  • do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients

corn starch, DandC Red #27 aluminum lake, edible black ink, FDandC Blue #1 aluminum lake, gelatin, glycerin, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, purified water, silicon dioxide, sodium starch glycolate, stearic acid and titanium dioxide.

Questions or comments?

call toll free: 1-877-753-3935

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® PM

Principal Display Panel

Compare to the active ingredients in Tylenol PM (R)
NDC: 59726-360-50

SEE NEW WARNING INFORMATION

Pain Relief PM
Acetaminophen, 500mg  -  Diphenhydramine, HCl 25mg
Pain Reliever/Nighttime Sleep Aid
 50geltabs

Product Package Label

Extra Strength Pain Relief PM

Product Carton Label

Extra Strength Pain Relief PM
EXTRA STRENGTH PAIN RELIEF PM 
acetaminophen, diphenhydramine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 59726-360
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
WATER (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBLUE (BLUE) , WHITE (WHITE) Scoreno score
ShapeROUND (ROUND) Size12mm
FlavorImprint Code BPI50
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 59726-360-501 in 1 BOX09/02/201112/30/2016
150 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34309/02/201112/30/2016
Labeler - P & L Development, LLC (800014821)

Revised: 1/2020