Genexa Infants Pain And Fever Suspension
FDA Label NDC 69676-0042

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Genexa Inc. for the product Genexa Infants Pain And Fever (NDC 69676-0042). 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.

Label Section Quick Index

Other

Keep outer package for complete product information

Drug Facts

Bottle is safety sealed. DO NOT use if bottle seal is disturbed or missing.

Certified B Corporation

Certified Gluten-Free

CERTIFIED VEGAN

Patent Pending

Distributed by: Genexa Inc., Atlanta, GA 30318

genexa.com

Made in the USA with globally sourced ingredients

R-20210427

NDC 69676-0042-9

Otc - Active Ingredient

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Otc - Purpose

Purpose

Pain reliever/fever reducer

Indications & Usage

Uses

temporarily reduces fever and relieves minor aches and pains due to:

  • the common cold
  • headache
  • toothache
  • flu
  • sore throat

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.

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

Otc - When Using

When using this product, do not exceed recommended dose (see overdose warning)

Dosage & Administration

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 USING
  • mL = milliliter
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age
  • push air out of syringe. Insert syringe tip into the bottle opening
  • flip bottle upside down. Pull white part of syringe to correct dose
  • dispense liquid slowly into child's mouth, toward inner cheek
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • replace cap tightly to maintain child-resistant packaging

    • Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.

    WeightAgeDose
    under 24 lbs.under 2 yearsask a doctor
    24-35 lbs.2-3 years5 mL

Storage And Handling

Other information

store between 20-25°C (68-77°F)

Inactive Ingredient

Inactive ingredients organic agave syrup, organic blueberry flavor, natural citrus extract, non-GMO flavor, purified water

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