FDA.reportPublic FDA data

Children's Acetaminophen Chewable Tablets

Manufacturer
Genexa Inc.
Effective date
2025-02-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:55:45

Label at a glance#

ProductGenexa Childrens Acetaminophen
Active ingredientACETAMINOPHEN
Label structure11 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Acetaminophen 80 mg

OTC - PURPOSE SECTION

Purpose

Pain reliever/fever reducer

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

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.

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if your child has liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

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 SECTION

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
WeightAgeDose †
Under 24 lbs.Under 2 yearsAsk a doctor
24-35 lbs.2-3 years2 tablets
36-47 lbs.4-5 years3 tablets
48-59 lbs.6-8 years4 tablets
60-71 lbs.9-10 years5 tablets
72-95 lbs.11 years6 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 SECTION

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

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.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

10000-GNX_Kids-Pain-Fever_Chewable_Carton_2022_05_26 Approved10000-GNX_Kids-Pain-Fever_Chewable_Carton_2022_05_26 Approved

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307696acetaminophen 80 MG Chewable TabletPSN3
307696acetaminophen 80 MG Chewable TabletSCD3
307696APAP 80 MG Chewable TabletSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69676-0058-72025-02-20C16284748780-12cef2736-7b61-d83d-e063-dadaa90ab31fChildren's Acetaminophen Chewable Tablets
69676-0058-72025-01-30C16284748780-12cef2736-7b61-d83d-e063-dadaa90ab31fChildren's Acetaminophen Chewable Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69676-0058-7Genexa Childrens Acetaminophen24 in 1 BOTTLETABLET, CHEWABLE243
69676-0058-7Genexa Childrens Acetaminophen1 in 1 CARTONTABLET, CHEWABLE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69676-0058GENEXA CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) TABLET, CHEWABLE [GENEXA INC.]3Current NDC, Legacy NDC, 2 package rows20250223_d89fd9d8-d88e-3968-e053-2a95a90afc5f.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69676-005869676-0058-7

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
PALM OIL5QUO05548ZIACT
XYLITOLVCQ006KQ1EIACT
GUAR GUME89I1637KEIACT
MALTODEXTRIN7CVR7L4A2DIACT
GLYCERYL DIBEHENATER8WTH25YS2IACT
CALCIUM CARBONATEH0G9379FGKIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
STEVIA REBAUDIUNA LEAF6TC6NN0876IACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
CARNAUBA WAXR12CBM0EIZIACT
DEXTROSEIY9XDZ35W2IACT
ACACIA5C5403N26OIACT
ACETAMINOPHEN362O9ITL9DACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Genexa Childrens AcetaminophenACETAMINOPHENGenexa Inc.d89fd9d8-d88e-3968-e053-2a95a90afc5f2025-02-19WarningsExact identifier
ndc (package): 69676-0058-7
ndc (product): 69676-0058
ndc11 (package): 69676005807
spl id: 2e847ded-cf9d-14a7-e063-6394a90a8690
spl set id: d89fd9d8-d88e-3968-e053-2a95a90afc5f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.