FDA.reportPublic FDA data

Infants' Pain & Fever Oral Suspension

Manufacturer
Genexa Inc.
Effective date
2026-05-08
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:56:35

Label at a glance#

ProductGenexa Infants Pain and Fever
Active ingredientACETAMINOPHEN
Label structure13 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 - 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.

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
  • mL = milliliter
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • push air out of syringe. Insert syringe tip into the bottle opening, flip bottle upside down, pull white part of syringe to correct dose
  • dispense liquid slowly into child's mouth, toward inner cheek
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • replace cap tightly to maintain child-resistant packaging

Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.

WeightAgeDose
under 24 lbs.under 2 yearsask a doctor
24-35 lbs.2-3 years5 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 is disturbed or missing.

Distributed by: Genexa Inc., Atlanta, GA 30324

genexa.com

SPL UNCLASSIFIED SECTION

Made in the USA with globally sourced ingredients

NDC 69676-0042-9

RECENT MAJOR CHANGES 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
  • mL = milliliter
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • push air out of syringe. Insert syringe tip into the bottle opening, flip bottle upside down, pull white part of syringe to correct dose
  • dispense liquid slowly into child's mouth, toward inner cheek
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • replace cap tightly to maintain child-resistant packaging

Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.

Weight

Age Dose
under 24 lbs.under 2 yearsask a doctor
24-35 lbs.2-3 years5 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pediatrician Preferred #1 INGREDIENTS*

Genexa ®

CLEAN MEDICINE

Infants' 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

2 FL OZ (59 mL)

**Same as Genexa Kids' Pain Reliever & Fever Reducer

10068-GNX carton_R-2025111210068-GNX carton_R-20251112

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN8
307668acetaminophen 32 MG/ML Oral SuspensionSCD8
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY8
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY8
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY8
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY8
307668APAP 32 MG/ML Oral SuspensionSY8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69676-0042-9Genexa Infants Pain and Fever1 in 1 CARTONSUSPENSION18
69676-0042-9Genexa Infants Pain and Fever59 mL in 1 BOTTLESUSPENSION598

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
69676-004269676-0042-9

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
BLUEBERRY253RUG1X1AIACT
AGAVE TEQUILANA JUICEGVG8G0207OIACT
WATER059QF0KO0RIACT
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 Infants Pain and FeverACETAMINOPHENGenexa Inc.c59cbf0e-1381-4dd2-e053-2a95a90a853a2026-05-08WarningsExact identifier
ndc (package): 69676-0042-9
ndc (product): 69676-0042
ndc11 (package): 69676004209
spl id: 51588b9a-d5ac-4667-e063-6294a90a432c
spl set id: c59cbf0e-1381-4dd2-e053-2a95a90a853a

Reported adverse events (FAERS/openFDA)#

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