Active Ingredients (In Each Gummy)
Acetaminophen 160 mg.....Pain reliever/fever reducer
Children Pain Relief Gummy Chewable Gel
FDA Label NDC 87823-030
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gummy Usa for the product Children Pain Relief Gummy (NDC 87823-030). 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 active ingredients (in each gummy), uses, warnings, keep out of reach of children, otc - do not use, drug facts (continued), indications and usage, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
Temporarily relieves minor aches and pains due to:
- common cold
- flu
- headache
- sore throat
- toothache
- temporarily reduces fever
Warnings
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:
- more than 5 doses in 24 hours (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 davs, or is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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). Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
Chocking hazard: Not intended for children under 3 years of age. Keep out of reach of children. Parental supervision required.
Otc - 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.
- If your child is allergic to acetaminophen or any of the inactive ingredients in this product.
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 wafarin
Drug Facts (Continued)
When using this product do not exceed the 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.
Indications And Usage
Indications and Usage
Directions
- this product does not contain directions or complete warnings for adult use.
- do not give more than directed (see overdose warning).
- find the right dose on the chart below. If possible, use weight to dose; otherwise, use age.
- repeat dose every 4 hours while symptoms
- do not give more than 5 times in 24 hours
*or as directed by a doctor
Other Information
Do not use if safety seal is broken or missing. Store in a cool, dry place at 20–25°C (68–77°F). Protect from excessive heat and humidity.
Inactive Ingredients
Ascorbic Acid, Citric Acid, Natural Colors, Natural Flavors (Watermelon), Sucrose (from Citrus Fiber), Water.
Questions?
call 1-855-556-2131 (toll free)
Manufactured by Gummy USA for HYEX
U.S. Agent: Eknox · NDC: 87823-030-01
Recent Major Changes
Change all the dates to be effective 07/24/26
Package Label.Principal Display Panel
Drug Facts
* Please review the disclaimer below.
