GENEXA CHILDRENS ACETAMINOPHEN- acetaminophen tablet, chewable

Genexa Childrens Acetaminophen by

Drug Labeling and Warnings

Genexa Childrens 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 tablet)

Acetaminophen 80 mg

PURPOSE

Purpose

Pain reliever/fever reducer

INDICATIONS & USAGE

Uses

• temporarily relieves minor aches and pains due to:
• the common cold
• sore throat
• flu
• toothache
• headache
• temporarily reduces fever

WARNINGS

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

• more than 5 doses in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen

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.

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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 your child is allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if your child has liver disease

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

When using this product do not exceed recommended dose (see Overdose warning)

Stop use and ask a doctor if

• pain gets worse or lasts more than 5 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.

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

• this product does not contain directions or complete warnings for adult use.
• do not give more than directed (see Overdose warning)
• find right dose on chart below. If possible, use weight to dose; otherwise, use age.
• chew tablets completely before swallowing; do not swallow tablets whole
• repeat dose every 4 hours while symptoms last
• do not give more than 5 times in 24 hours

Weight	Age	Dose †
Under 24 lbs.	Under 2 years	Ask a doctor
24-35 lbs.	2-3 years	2 tablets
36-47 lbs.	4-5 years	3 tablets
48-59 lbs.	6-8 years	4 tablets
60-71 lbs.	9-10 years	5 tablets
72-95 lbs.	11 years	6 tablets

†or as directed by a doctor

OTHER SAFETY INFORMATION

Other information

• each tablet contains: calcium 10 mg
• store between 20-25°C (68-77°F). Avoid high humidity. Protect from light.

INACTIVE INGREDIENT

Inactive ingredients

acacia gum‡, calcium carbonate‡, organic carnauba wax, cellulose‡, citric acid‡, dextrose‡, dibehenin (vegetable source)‡, flavor‡, glycerin‡, grape flavor‡, organic guar gum, maltodextrin‡, organic palm olein, organic stevia rebaudiana leaf extract, organic

sunflower lecithin, xylitol‡

‡ 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 Inc., owner of the registered trademark Children's Tylenol® Chewables Grape.

Patent Pending | Distributed by: Genexa Inc.

Atlanta, GA 30318 | genexa.com

Made in the USA with globally sourced ingredients

R-20211230

NDC: 69676-0058-7

PRINCIPAL DISPLAY PANEL

Children's

Genexa®

MEDICINE MADE CLEAN

Ages 2-11

Acetaminophen Chewables

Pain Reliever Fever Reducer

How we're different

Made without: crospovidone, D&C red no. 30 aluminum lake, sucralose & more!

Read our label vs. Children'sTylenol® Chewables Grape*

24 Chewable Tablets

80 mg each

Grape Flavor

INGREDIENTS AND APPEARANCE

GENEXA CHILDRENS ACETAMINOPHEN 
acetaminophen tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69676-0058
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	80 mg

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
PALM OIL (UNII: 5QUO05548Z)
XYLITOL (UNII: VCQ006KQ1E)
GUAR GUM (UNII: E89I1637KE)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
CALCIUM CARBONATE (UNII: H0G9379FGK)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
CARNAUBA WAX (UNII: R12CBM0EIZ)
DEXTROSE (UNII: IY9XDZ35W2)
ACACIA (UNII: 5C5403N26O)

Product Characteristics
Color	white (LIGHT BEIGE WITH SPECKLES)	Score	no score
Shape	ROUND	Size	20mm
Flavor	GRAPE	Imprint Code	G10
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69676-0058-7	1 in 1 CARTON	02/28/2022
1		24 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	02/28/2022

Labeler - Genexa Inc. (079751024)