FDA.reportPublic FDA data

Childrens Acetaminophen Oral Suspension

Manufacturer
Genexa Inc.
Effective date
2024-01-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:06:37

Label at a glance#

ProductChildrens Acetaminophen Oral Suspension
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 - 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 USING
  • 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
WeightAgeDose
under 24 lbs.under 2 yearsask a doctor
24-35lbs.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

organic agave syrup, organic blueberry flavor, natural citrus extract, flavor, purified water

OTC - QUESTIONS SECTION

Questions?1-855-436-3921

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Johnson & Johnson Corp., owner of the registered trademark Children's Tylenol® Oral Suspension Grape.

SPL UNCLASSIFIED SECTION

Give it a SHAKE! We use clean ingredients so it's normal for them to separate and change color over time.

Bottle is safety sealed with a perforated band around bottle. DO NOT use if bottle seal is distrubed or missing.

Certified B Corporation

CERTIFIED GLUTEN FREE GFCO.ORG

CERTIFIED VEGAN VEGAN.ORG

Patent Pending | Distributed by: Genexa Inc.

Atlanta, GA 30318 | genexa.com

SPL UNCLASSIFIED SECTION

Made in the USA with globally sourced ingredients

NDC 69676-0069-9

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Children's

Genexa®

MEDICINE MADE CLEAN

Ages 2-11

Acetaminophen

160 mg per 5 mL | Oral Suspension

Pain Reliever Fever Reducer

Compare to active ingredient in Children's Tylenol® Oral Suspension Grape

How we're different

Made without: high fructose corn syrup, FD&C blue no. 1, D&C red no. 33 & more!

Organic Blueberry Flavor

Ibuprofen Free, Aspirin Free

4 fl oz (118 mL) Dosing cup included

39A_Pain-and-Fever_Childrens_Carton_R-2022011339A_Pain-and-Fever_Childrens_Carton_R-20220113

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN2
307668acetaminophen 32 MG/ML Oral SuspensionSCD2
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY2
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY2
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY2
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY2
307668APAP 32 MG/ML Oral SuspensionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69676-0069-9Childrens Acetaminophen Oral Suspension118 mL in 1 BOTTLE, PLASTICSUSPENSION1182
69676-0069-9Childrens Acetaminophen Oral Suspension1 in 1 CARTONSUSPENSION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69676-0069CHILDRENS ACETAMINOPHEN ORAL SUSPENSION (ACETAMINOPHEN) SUSPENSION [GENEXA INC.]22 package rows20240105_0c659735-9810-912a-e063-6294a90a9051.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69676-006969676-0069-9

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
WATER059QF0KO0RIACT
CITRUS FRUITXDK00Z8012IACT
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
0e1068bb-e2db-4820-e063-6294a90a91610c659735-9810-912a-e063-6294a90a90512024-01-03WarningsExact identifier
spl id: 0e1068bb-e2db-4820-e063-6294a90a9161
spl set id: 0c659735-9810-912a-e063-6294a90a9051

Reported adverse events (FAERS/openFDA)#

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