Kids Pain and Fever
Kids' Pain & Fever Organic Cherry Flavor
f7e6e984-f0c3-ed40-e053-6294a90a89f7
HUMAN OTC DRUG LABEL
May 23, 2025
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
Product Classification
Product Specifications
INGREDIENTS (4)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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
INDICATIONS & USAGE SECTION
Uses
temporarily reduces fever and relieves minor aches and pains due to:
- the common cold
- headache
- toothache
- flu
- sore throat
SPL UNCLASSIFIED SECTION
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
Active ingredient (in each 5 mL)
Acetaminophen 160 mg
OTC - PURPOSE SECTION
Purpose
Pain reliever/fever reducer
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.
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
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
Other information
store between 20-25°C (68-77°F)
INACTIVE INGREDIENT SECTION
Inactive ingredients
organic agave syrup, organic cherry flavor, natural flavors, purified water
OTC - QUESTIONS SECTION
Questions?
1-855-436-3921