FDA.reportPublic FDA data

Kids' Pain & Fever

Manufacturer
Genexa Inc.
Effective date
2026-05-08
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 01:57:00

Label at a glance#

ProductKids Pain and Fever
Active ingredientACETAMINOPHEN
Label structure11 sections

Storage and handling

Other information store between 20-25°C (68-77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

OTC - PURPOSE SECTION

Purpose

Pain reliever/fever reducer

INDICATIONS & USAGE SECTION

Uses
temporarily reduces fever and relieves minor aches and pains due to:

  • the common cold
  • headache
  • toothache
  • flu
  • sore throat

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.

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 - 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.

SPL UNCLASSIFIED 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 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)
  • SHAKE WELL BEFORE EACH USE
  • find right dose on chart below
  • for accurate dosing, use measuring cup provided.
  • Do not use with any other dosing device.
  • give dose every 4 hours while symptoms last
  • if possible, use weight to dose; otherwise, use age
  • do not give more than 5 times in 24 hours
WeightUse Age Dose
under 24 lbs.under 2 yearsask a doctor
24-35 lbs.2-3 years5 mL
36-47 lbs.4-5 years7.5 mL
48-59 lbs.6-8 years10 mL
60-71 lbs.9-10 years12.5 mL
72-95 lbs.11 years15 mL

STORAGE AND HANDLING SECTION

Other information

store between 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

agave syrup (organic), blueberry flavor (organic), flavors (natural), purified water

OTC - QUESTIONS SECTION

Questions?

1-855-436-3921

SPL UNCLASSIFIED SECTION

*When compared to the ingredient profiles in the leading brand's top-selling comparable products. (FRC2025)

SHAKE WELL BEFORE EACH USE

DO NOT use if perforated band around the bottle seal is disturbed or missing.

Made in the USA with globally sourced ingredients

Distributed by: Genexa Inc., Atlanta, GA 30324

genexa.com

NDC 69676-0041-9

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pediatrician Preferred #1 INGREDIENTS*

Genexa ®

CLEAN MEDICINE

Ages 2-11

Kids' Pain Reliever & Fever Reducer

Acetaminophen

160 mg per 5 mL / Oral Suspension

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

Made with Real Agave + Blueberry Flavoring

4 FL OZ (118 mL)

39A carton_R-2025111139A carton_R-20251111

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN12
307668acetaminophen 32 MG/ML Oral SuspensionSCD12
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY12
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY12
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY12
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY12
307668APAP 32 MG/ML Oral SuspensionSY12

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69676-0041-32025-02-21C16284748780-12cef2736-9b69-d83d-e063-dadaa90ab31fKids' Pain & Fever
69676-0041-92025-02-21C16284748780-12cef2736-9b69-d83d-e063-dadaa90ab31fKids' Pain & Fever
69676-0041-32025-01-30C16284748780-12cef2736-9b69-d83d-e063-dadaa90ab31fKids' Pain & Fever
69676-0041-92025-01-30C16284748780-12cef2736-9b69-d83d-e063-dadaa90ab31fKids' Pain & Fever

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69676-0041-3Kids Pain and Fever5 mL in 1 POUCHLIQUID512
69676-0041-9Kids Pain and Fever118 mL in 1 BOTTLE, PLASTICLIQUID11812
69676-0041-9Kids Pain and Fever1 in 1 CARTONLIQUID112

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69676-004169676-0041-9, 69676-0041-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ACETAMINOPHEN362O9ITL9DACTIB
BLUEBERRY253RUG1X1AIACT
AGAVE TEQUILANA JUICEGVG8G0207OIACT

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
Kids Pain and FeverACETAMINOPHENGenexa Inc.a7bd0b92-6f85-6175-e053-2995a90ab8372026-05-08WarningsExact identifier
ndc (package): 69676-0041-9
ndc (package): 69676-0041-3
ndc (product): 69676-0041
ndc11 (package): 69676004109
ndc11 (package): 69676004103
spl id: 51597a5f-8ed4-7534-e063-6394a90a859a
spl set id: a7bd0b92-6f85-6175-e053-2995a90ab837

Reported adverse events (FAERS/openFDA)#

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