PAIN RELIEF PM- acetaminophen, diphenhydramine tablet 
Pioneer Life Sciences, LLC

----------

Pain Relief PM

Active Ingredients (in each caplet)

Acetaminophen 500 mg

Diphenhydramine 25 mg

Purpose

Acetaminophen 500 mg ....................................................................................................................................Pain reliever
Diphenhydramine HCl 25 mg ...........................................................................….................................Nighttime sleep aid

Uses:

Warnings:

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take ■ more than 4,000 mg of acetaminophen in 24 hrs ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks every day while using this product.

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash. 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 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

■ glaucoma

■ a breathing problem such as emphysema or chronic bronchitis

■ trouble urinating due to an enlarged prostate gland.

Ask a doctor or pharmacist before use if you are 

When using this product

■ drowsiness will occur

■ avoid alcoholic drinks

■ do not drive a motor vehicle or operate machinery.

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 Poison Control (1-800-222-1222) 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 at bedtime

■ do not take more than 2 caplets in 24 hours unless directed by a doctor

■ children under 12 years do not use

Other Information:

Inactive Ingredients:

FD & C Blue # 1, FD & C Blue # 2, Hypromellose, Microcrystalline Cellulose, Magnesium Stearate, Polyethylene glycol 400, Pregelatinized Starch, Polyvinyl Pyrrolidone, Stearic Acid Powder, Titanium Dioxide.

Questions or Comments?

Call 1-732-698-5070 Monday through Friday 9am to 5pm EST or visit www.pioneerlifesciences.com

This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare
Division., owner of the registered trademark Tylenol® Extra Strength Tablets.

Distributed by: GenCare Consumer Products, LLC 40E Cotters Ln Suite A, East Brunswick, NJ 08816

PL0035-Rev 01 Pain Relief PM- 375ct - Elysium 08.02.2023_page-0001

PAIN RELIEF PM 
acetaminophen, diphenhydramine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72090-006
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Magnesium Stearate (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorblueScoreno score
ShapeCAPSULESize27mm
FlavorImprint Code None
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72090-006-25375 in 1 BOTTLE; Type 0: Not a Combination Product05/08/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01305/08/2024
Labeler - Pioneer Life Sciences, LLC (014092742)
Registrant - Pioneer Life Sciences, LLC (014092742)

Revised: 5/2024
Document Id: 260f4d09-95b5-4530-9b52-3900a6d47e91
Set id: ad29a37f-39a2-5c84-e053-2995a90a2f39
Version: 3
Effective Time: 20240508
 
Pioneer Life Sciences, LLC