Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameACETAMINOPHEN
Labeler / manufacturerGenexa Inc.
RouteORAL
Drug classDrug class not supplied in source label
Product NDC69676-0101
Label effective date2026-08-31
Official product label reference
Genexa Kids Pain and Fever — Genexa Inc.
This page contains 15 source sections for ACETAMINOPHEN, oral route. Label set 5a615118-33c9-1520-e063-6394a90a21a6, version 1.
Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.
Uses described in the label
Uses temporarily reduces fever and relieves minor aches and pains due to: the common cold headache toothache flu sore throat
Purpose
Purpose Pain reliever/fever reducer
Dosage and administration — label text
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
Table text from source:
| 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
Warnings
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 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. 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 When using this product do not exceed recommended dose (see overdose warning) 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.
Unclassified section
Drug Facts
Other information each 5mL contains: sodium 3 mg store between 20-25°C (68-77°F)
*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 Made in the USA with globally sourced ingredients Distributed by: Genexa Inc., Atlanta, GA 30324 genexa.com NDC 69676-0101-3
Active ingredient
Active ingredient (in each 5 mL) Acetaminophen 160 mg
Do not use
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.
Ask a doctor before use
Ask a doctor before use if your child has liver disease
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin
While using this medicine
When using this product do not exceed recommended dose (see overdose warning)
When to stop use and seek help
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.
Child safety
Keep out of reach of children.
Overdose information
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.
The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.