ACETAMINOPHEN PM- acetaminophen 500mg / diphenhydramine hcl 25mg tablet, film coated 
Ulai Health 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 ingredients (in each caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Purpose

Pain reliever

Nighttime sleep aid

Uses

temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

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 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 a pharmacist.
  • with any other product containing diphenhydramine, even one used on skin
  • in children under 12 years of age
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • glaucoma

When using this product

  • drowsiness will occur
  • avoid alcoholic drinks
  • do not drive a motor vehicle or operating machinery

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

Stop use and ask a doctor if

  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur

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 (1-800-222-1222).

Directions

adults and children 12 years and over

  • take 2 caplets at bedtime
  • do not take more than 2 caplets of this product in 24 hours

children under 12 years

do not use

Other information

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, FD&C Blue #1, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized corn starch, purified water, stearic acid, titanium dioxide

Questions or comments?

(866) 562-2756 (Mon - Fri 8 AM to 4 PM EST)

PHARBEST

NDC 73057-352-03

Manufactured in the USA

Extra Strength

*COMPARE TO the active ingredients in TYLENOL ® PM

ACETAMINOPHEN

PM

Pain Reliever

Nighttime Sleep Aid

Acetaminophen,

Diphenhydramine HCl

Non-habit forming

24 Caplets

Ulai Pharbetol PM Caplet 24 ct. Label

ACETAMINOPHEN PM 
acetaminophen 500mg / diphenhydramine hcl 25mg tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73057-352
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorblue (Light Blue color tablet) Scoreno score
ShapeCAPSULE (Capsule Shaped tablet) Size18mm
FlavorImprint Code PH019
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73057-352-0324 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34307/08/2019
Labeler - Ulai Health LLC (081181535)

Revised: 1/2022
Document Id: d6e761d5-7742-a025-e053-2a95a90a871c
Set id: d4a568c9-a721-48d1-aebc-fc65444947ce
Version: 3
Effective Time: 20220131
 
Ulai Health LLC