The following Structured Product Label (SPL) was submitted to the FDA by Genexa Inc. for the product Kids Pain And Fever (NDC 69676-0041). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
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.
Bottle is safety sealed. DO NOT use if bottle seal is disturbed or missing.
Patent Pending | Distributed by: Genexa Inc.
Los Angeles, CA 90034 | genexa.com
Made in the USA with globally sourced ingredients
NDC 69676-0041-9
Active ingredient (in each 5 mL)
Acetaminophen 160 mg
Purpose
Pain reliever/fever reducer
Uses
temporarily reduces fever and relieves minor aches and pains due to:
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
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
Stop use and ask a doctor if
These could be signs of a serious condition.
Keep out of reach of children.
Directions
| 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 |
Other information
store between 20-25°C (68-77°F)
Inactive ingredients oganic agave syrup, organic blueberry flavor, natural citrus extract, non-GMO flavor, purified water
Questions?
1-855-436-3921 Mon.-Fri. 7am - 6pm PST
Genexa
REAL MEDICINE MADE CLEAN
Kids' Pain & Fever
Pain Fever
Acetaminophen 160 mg per 5 mL
Pain Reliever-Fever Reducer
Flavored with Organic Blueberries
No allergens, dyes, or parabens
Ages 2+ Dosing cup included
4 FL OZ (118 mL) Liquid
* Please review the disclaimer below.
