GENEXA ACETAMINOPHEN PM EXTRA STRENGTH- acetaminophen tablet, coated 
Genexa Inc.

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Acetaminophen PM Extra Strength Caplets

Drug Facts

Active ingredients (in each caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Purpose

Pain reliever

Nighttime sleep aid

Uses

temporarily relieves 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 pharmacist.
  • with any other product containing diphenhydramine, even one used on the 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

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

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 a Poison Control Center right away (1-800-222-1222). Prompt 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 if needed
  • do not take more than 2 caplets in 24 hours, unless directed by a doctor
children under 12 yearsask a doctor

Other information

Inactive ingredients

acacia gum‡, agave fiber‡, agave syrup‡, calcium carbonate‡, organic carnauba wax, cellulose‡, dextrose‡, dibehenin (vegetable source)‡, glycerin‡, guar gum‡, maltodextrin‡, organic palm olein, rice extract‡, rice hulls‡, sodium bicarbonate‡, organic sunflower lecithin, sunflower oil‡

‡natural

Questions? 1-855-436-3921

Carton and bottle are safety sealed. DO NOT use if seal on top and/or bottom of carton or under cap of bottle is disturbed or missing.

*This product is not manufactured or distributed by Johnson & Johnson Corp., owner of the registered trademark Tylenol® PM Extra Strength Caplets.

Patent Pending | Distributed by: Genexa Inc.

Atlanta, GA 30318 | genexa.com

Made in the USA with globally sourced ingredients

NDC 69676-0063-2

Genexa®

MEDICINE MADE CLEAN

For Adults

Acetaminophen PM Extra Strength

with Diphenhydramine HCl

Pain Reliever Nighttime Sleep Aid

Compare to active ingredients in Tylenol® PM Extra Strength Caplets*

100 Caplets

Non-habit forming

How we're different

Made without: crospovidone, polyethylene glycol, titanium dioxide & more!

Adult APAP PM_Carton_R-20220323

GENEXA ACETAMINOPHEN PM  EXTRA STRENGTH
acetaminophen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69676-0063
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
CALCIUM CARBONATE (UNII: H0G9379FGK)  
RICE BRAN (UNII: R60QEP13IC)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
INULIN (UNII: JOS53KRJ01)  
PALM OIL (UNII: 5QUO05548Z)  
ACACIA (UNII: 5C5403N26O)  
AGAVE TEQUILANA JUICE (UNII: GVG8G0207O)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
DEXTROSE (UNII: IY9XDZ35W2)  
GUAR GUM (UNII: E89I1637KE)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
Colorwhite (LIGHT BEIGE WITH SPECKLES) Scoreno score
ShapeOVAL (Oblong) Size18mm
FlavorImprint Code G7
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69676-0063-21 in 1 CARTON02/17/2022
1100 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:69676-0063-51 in 1 CARTON02/17/2022
250 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01302/17/2022
Labeler - Genexa Inc. (079751024)

Revised: 12/2023
Document Id: 0c51f135-ce39-35e9-e063-6294a90acb8b
Set id: d82cf6f3-a291-ca2b-e053-2a95a90a6de1
Version: 4
Effective Time: 20231212
 
Genexa Inc.