FDA.reportPublic FDA data

Kids Pain and Fever Chewable Tablets

Manufacturer
Genexa, Inc.
Effective date
2026-05-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:57:37

Label at a glance#

ProductGenexa Kids Pain and Fever
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
• flu
• headache
• sore throat
• toothache
• 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 oC (68-77 oF). Avoid high humidity. Protect from light.

INACTIVE INGREDIENT SECTION

Inactive ingredients

acacia gum ‡, calcium carbonate ‡, carnauba wax (organic), cellulose ‡, citric acid ‡, dextrose ‡, dibehenin (vegetable source) ‡, flavors ‡, glycerin ‡, guar gum (organic), maltodextrin ‡, stevia rebaudiana leaf extract (organic), sunflower lecithin (organic), sunflower oil (organic), xylitol ‡

‡ natural

OTC - QUESTIONS SECTION

Questions? 1-855-436-3921

SPL UNCLASSIFIED SECTION

DO NOT use if seal on top and bottom of carton and under cap of bottle is disturbed or missing.

Distributed by: Genexa Inc., Atlanta, GA 30324

genexa.com

NDC 69676-0081-7

Made in the USA with globally sourced ingredients

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Genexa ®

CLEAN MEDICINE

Ages 2-11

Kids' Pain Reliever & Fever Reducer

Acetaminophen

80 mg Chewable Tablets

Pain Reliever

Fever Reducer

0% Artificial Additives, Dyes, Artificial Sweeteners, Common Allergens

Made with Grape Flavoring

24 Chewable Tablets

80 mg each

10000-GNX carton R-2025112110000-GNX carton R-20251121

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307696acetaminophen 80 MG Chewable TabletPSN4
307696acetaminophen 80 MG Chewable TabletSCD4
307696APAP 80 MG Chewable TabletSY4

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850015736100GTIN-13: 0850015736100
EAN-13: 0850015736100
GTIN-12: 850015736100
UPC-A: 850015736100
GTIN storage (14 digits): 00850015736100		10000-GNX carton R-20251121.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69676-0081-72025-02-21C16284748780-12cef2736-a610-d83d-e063-dadaa90ab31fKids Pain and Fever Chewable Tablets
69676-0081-72025-01-30C16284748780-12cef2736-a610-d83d-e063-dadaa90ab31fKids Pain and Fever Chewable Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69676-0081-7Genexa Kids Pain and Fever24 in 1 BOTTLETABLET, CHEWABLE244
69676-0081-7Genexa Kids Pain and Fever1 in 1 CARTONTABLET, CHEWABLE14

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
69676-008169676-0081-7

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
MALTODEXTRIN7CVR7L4A2DIACT
STEVIA REBAUDIUNA LEAF6TC6NN0876IACT
DEXTROSEIY9XDZ35W2IACT
CARNAUBA WAXR12CBM0EIZIACT
GUAR GUME89I1637KEIACT
CALCIUM CARBONATEH0G9379FGKIACT
GLYCERINPDC6A3C0OXIACT
XYLITOLVCQ006KQ1EIACT
ACACIA5C5403N26OIACT
SUNFLOWER OIL3W1JG795YIIACT
ACETAMINOPHEN362O9ITL9DACTIB
GLYCERYL DIBEHENATER8WTH25YS2IACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT

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 Kids Pain and FeverACETAMINOPHENGenexa, Inc.091dd1e7-2484-cdbf-e063-6394a90a21892026-05-11WarningsExact identifier
ndc (package): 69676-0081-7
ndc (product): 69676-0081
ndc11 (package): 69676008107
spl id: 5193e87a-374d-a695-e063-6394a90a79d2
spl set id: 091dd1e7-2484-cdbf-e063-6394a90a2189

Reported adverse events (FAERS/openFDA)#

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