GENEXA ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet, coated

Genexa Acetaminophen by

Drug Labeling and Warnings

Genexa Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Genexa Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each caplet)

Acetaminophen 500 mg

PURPOSE

Purpose

Pain reliever/fever reducer

INDICATIONS & USAGE

Uses

• temporarily relieves minor aches and pains due to:
  • the common cold
  • headache
  • backache
  • minor pain of arthritis
  • toothache
  • muscular aches
  • premenstrual and menstrual cramps
• temporarily reduces fever

WARNINGS

Warnings

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if you take

• more than 4,000 mg of acetaminophen in 24 hours
• 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
• if you are allergic to acetaminophen or any of the inactive ingredients in this product.

Ask a doctor before use if you have liver disease

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• new symptoms occur
• redness or swelling is present

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.

DOSAGE & ADMINISTRATION

Directions

do not take more than directed (see Overdose warning)

adults and children 12 years and over

• take 2 caplets every 6 hours while symptoms last
• do not take more than 6 caplets in 24 hours, unless directed by a doctor
• do not use for more than 10 days, unless directed by a doctor

children under 12 years

ask a doctor

OTHER SAFETY INFORMATION

Other information

• each caplet contains: calcium 12 mg
• store between 20-25°C (68-77°F)

INACTIVE INGREDIENT

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

Questions? 1-855-436-3921

SPL UNCLASSIFIED SECTION

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® Extra Strength Caplets.

Patent Pending | Distributed by: Genexa Inc.

Atlanta, GA 30318 | genexa.com

Made in the USA with globally sourced ingredients

NDC: 69676-0059-2

R-20220323

PRINCIPAL DISPLAY PANEL

Genexa®

MEDICINE MADE CLEAN

For Adults

Acetaminophen Extra Strength

Pain Reliever Fever Reducer

Compare to active ingredient in Tylenol® Extra Strength Caplets*

100 Caplets 500 mg each

How we're different

Made without: FD&C red no. 40 aluminum lake, titanium dioxide, propylene glycol & more!

INGREDIENTS AND APPEARANCE

GENEXA ACETAMINOPHEN  EXTRA STRENGTH
acetaminophen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69676-0059
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
INULIN (UNII: JOS53KRJ01)
ACACIA (UNII: 5C5403N26O)
GUAR GUM (UNII: E89I1637KE)
AGAVE TEQUILANA JUICE (UNII: GVG8G0207O)
CARNAUBA WAX (UNII: R12CBM0EIZ)
DEXTROSE (UNII: IY9XDZ35W2)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
CALCIUM CARBONATE (UNII: H0G9379FGK)
RICE BRAN (UNII: R60QEP13IC)
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
SUNFLOWER OIL (UNII: 3W1JG795YI)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
GLYCERIN (UNII: PDC6A3C0OX)
PALM OIL (UNII: 5QUO05548Z)

Product Characteristics
Color	white (LIGHT BEIGE WITH SPECKLES)	Score	no score
Shape	OVAL (Oblong)	Size	18mm
Flavor		Imprint Code	G4
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69676-0059-2	1 in 1 CARTON	02/17/2022
1		100 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 69676-0059-5	1 in 1 CARTON	02/17/2022
2		50 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	02/17/2022

Labeler - Genexa Inc. (079751024)