Kids Pain & Fever Oral Suspension
- Manufacturer
- Genexa Inc.
- Effective date
- 2026-05-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- monthly-update
- Hydrated at
- 2026-07-17 21:34:52
Label at a glance#
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 - 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.
OVERDOSAGE 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 |
SPL UNCLASSIFIED SECTION
Other information
- store between 20-25 ºC (68-77 ºF)
INACTIVE INGREDIENT SECTION
Inactive ingredients
agave syrup (organic), blueberry flavor (organic), flavors (natural), purified water, sodium bicarbonate (natural) †
†may contain this ingredient
OTC - QUESTIONS SECTION
Questions? 1-855-436-3921
SPL UNCLASSIFIED SECTION
Made in the USA with globally sourced ingredients
NDC 69676-0099-9
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
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
Pediatrician Preferred #1 INGREDIENTS*
Genexa ®
CLEAN MEDICINE
Kids' Pain Reliever & Fever Reducer
Ages 2-11
ACETAMINOPHEN
160 mg per 5 mL / Oral Suspension
0% Artificial Additives, Dyes, Artificial Sweeteners, Common Allergens
Made with Real Agave + Blueberry Flavoring
4 FL OZ (118 mL)
DailyMed Product Concepts#
Products#
Every source-derived product name is available through these pages.
- Genexa Kids Pain and Fever
- Acetaminophen
- SODIUM BICARBONATE
- WATER
- BLUEBERRY
- AGAVE TEQUILANA JUICE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69676-0099 | 69676-0099-9 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM BICARBONATE | 8MDF5V39QO | IACT |
| WATER | 059QF0KO0R | IACT |
| BLUEBERRY | 253RUG1X1A | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| AGAVE TEQUILANA JUICE | GVG8G0207O | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 1 | 2026-05-06 | full-release | 2026-06-01 01:56:16 |
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 |
|---|---|---|---|---|---|---|
| Genexa Kids Pain and Fever | ACETAMINOPHEN | Genexa Inc. | 5130c695-a80e-2dd3-e063-6294a90a404f | 2026-05-28 | Warnings | 69676-0099-9 69676-0099 69676009909 52eb2d4d-7c7c-17eb-e063-6394a90a7cbf 5130c695-a80e-2dd3-e063-6294a90a404f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
