EXTRA STRENGTH ACETAMINOPHEN PM- acetaminophen, diphenhydramine hydrochloride capsule, liquid filled 
Strategic Sourcing Services 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 Acetaminophen 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 drinks every day while using this product

Overdose warning:Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Do not use

with other product containing acetaminophen (prescription or non prescription) if you are not sure whether a drug contain acetaminophen ask a doctor or pharmacist

Ask a doctor before use if you have

  • liver disease
  • asthma
  • glaucaoma

Ask a doctor or pharmacist before use if you are

  • taking sedative or tranquilizers

When using this product

  • drowsiness will occur
  • avoid alcoholic drinks

Stop use and ask a doctor

  • new symptoms occur
  • pain gets worse or last more than 10 days
  • fever gets worse or last more than 3 days

If pregnant or breast-feeding

ask a health care or professional before use

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


Product Package Label

Extra Strength Pain Relief PM

Product Carton Label

Extra Strength Pain Relief PM
EXTRA STRENGTH ACETAMINOPHEN PM 
acetaminophen, diphenhydramine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62011-0024
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) Size13mm
FlavorImprint Code BP50
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62011-0024-11 in 1 BOX04/09/201210/01/2019
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 FINALpart34304/09/201210/01/2019
Labeler - Strategic Sourcing Services LLC (116956644)

Revised: 9/2019
 
Strategic Sourcing Services LLC