Storage and handling
Other information store between 20-25°C (68-77°F)
Kids Pain and Fever
- Manufacturer
- Genexa Inc.
- Effective date
- 2025-05-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:01:32
Label at a glance#
ProductKids Pain and Fever
Active ingredientACETAMINOPHEN
Label structure13 sections
Contacts and useful links#
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
| 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
SPL UNCLASSIFIED SECTION
*This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Children's Tylenol ® Oral Suspension Grape.
Made in the USA with globally sourced ingredients
NDC 69676-0089-9
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
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
- 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 |
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
VALUE 2-PACK
Genexa ®
MEDICINE MADE CLEAN
Ages 2-11
Kids' Pain & Fever
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
TWO - 4 FL OZ (118 mL) BOTTLES
TOTAL - 8 FL OZ (236 mL)
Cherry Flavor
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 307668 | acetaminophen 160 MG in 5 mL Oral Suspension | PSN | 2 |
| 307668 | acetaminophen 32 MG/ML Oral Suspension | SCD | 2 |
| 307668 | acetaminophen 160 MG per 5 ML Oral Suspension | SY | 2 |
| 307668 | acetaminophen 320 MG per 10 ML Oral Suspension | SY | 2 |
| 307668 | acetaminophen 650 MG per 20.3 ML Oral Suspension | SY | 2 |
| 307668 | acetaminophen 80 MG per 2.5 ML Oral Suspension | SY | 2 |
| 307668 | APAP 32 MG/ML Oral Suspension | SY | 2 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69676-0089-9 | 2025-05-23 | C162847 | 48780-1 | 2cef2736-822e-d83d-e063-dadaa90ab31f | Kids' Pain & Fever Organic Cherry Flavor (2 Pack) |
| 69676-0089-9 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-822e-d83d-e063-dadaa90ab31f | Kids' Pain & Fever Organic Cherry Flavor (2 Pack) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69676-0089-9 | Kids Pain and Fever | 118 mL in 1 BOTTLE, PLASTIC | LIQUID | 118 | 2 | |
| 69676-0089-9 | Kids Pain and Fever | 2 in 1 CARTON | LIQUID | 2 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69676-0089 | KIDS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [GENEXA INC.] | 2 | Current NDC, 2 package rows | 20250525_fcffa7e6-145c-6bc0-e053-6294a90a4751.zip |
Products#
Every source-derived product name is available through these pages.
- Kids Pain and Fever
- Acetaminophen
- CHERRY
- AGAVE TEQUILANA JUICE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69676-0089 | 69676-0089-9 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CHERRY | BUC5I9595W | IACT |
| AGAVE TEQUILANA JUICE | GVG8G0207O | IACT |
| WATER | 059QF0KO0R | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Kids Pain and Fever | ACETAMINOPHEN | Genexa Inc. | fcffa7e6-145c-6bc0-e053-6294a90a4751 | 2025-05-23 | Warnings | 69676-0089-9 69676-0089 69676008909 35d00d8c-b098-0878-e063-6294a90a5af9 fcffa7e6-145c-6bc0-e053-6294a90a4751 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.