MedPath

Kids Pain and Fever

Kids' Pain & Fever Organic Cherry Flavor

Approved
Approval ID

f7e6e984-f0c3-ed40-e053-6294a90a89f7

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 23, 2025

Manufacturers
FDA

Genexa Inc.

DUNS: 079751024

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Acetaminophen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69676-0084
Application NumberM013
Product Classification
M
Marketing Category
C200263
G
Generic Name
Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateMay 23, 2025
FDA Product Classification

INGREDIENTS (4)

CHERRYInactive
Code: BUC5I9595W
Classification: IACT
AGAVE TEQUILANA JUICEInactive
Code: GVG8G0207O
Classification: IACT
ACETAMINOPHENActive
Quantity: 160 mg in 5 mL
Code: 362O9ITL9D
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 2/28/2023

Genexa**®**

MEDICINE MADE CLEAN

Kids' Pain & Fever

Ages 2-11

Acetaminophen

160 mg per 5 mL | Oral Suspension
Pain Reliever Fever Reducer

Same active ingredient as** Children’s Tylenol****®***

0% Artificial Additives

Always free of common allergens, artificial preservatives, flavors, & dyes

4 fl oz (118 mL)

Cherry Flavor

10033-GNX_carton_R-20241210

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/1/2020

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

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/23/2025

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 | U.S. Patent No. 11,617,795

  • This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Children's Tylenol ® Oral Suspension Grape.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/1/2020

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/1/2020

Purpose

Pain reliever/fever reducer

WARNINGS SECTION

LOINC: 34071-1Updated: 7/1/2020

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.

Do not usewith any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if your child has liver disease

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

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.

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

LOINC: 34068-7Updated: 5/23/2025

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

Weight

Age

Dose

under 24 lbs.

under 2 years

ask a doctor

24-35 lbs.

2-3 years

5 mL

36-47 lbs.

4-5 years

7.5 mL

48-59 lbs.

6-8 years

10 mL

60-71 lbs.

9-10 years

12.5 mL

72-95 lbs.

11 years

15 mL

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 7/1/2020

Other information

store between 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/23/2025

Inactive ingredients

organic agave syrup, organic cherry flavor, natural flavors, purified water

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 2/28/2023

Questions?

1-855-436-3921

RECENT MAJOR CHANGES SECTION

LOINC: 43683-2Updated: 5/23/2025

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Kids Pain and Fever - FDA Drug Approval Details