Active Ingredient (In Each Tablet)
Acetaminophen 80 mg
Premier Value Childrens Acetaminophen Melts
FDA Label NDC 68016-196
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Consortium for the product Premier Value Childrens Acetaminophen Melts (NDC 68016-196). 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 ingredient (in each tablet), purpose, uses, warnings, do not use, ask a doctor before use if your child has, ask a doctor or pharmacist before use if your child is, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- the common cold
- headache
- flu
- sore throat
- toothache
- temporarily reduces fever
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
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.
- 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 warfarin.
When Using This Product
do not exceed recommended dosage.
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: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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 chart. If possible, use weight to dose; otherwise, use age.
- Chew before swallowing; this product will soften in mouth for ease of chewing
- repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
- do not give for more than 5 days unless directed by a doctor
Weight (lb) | Age (yr) | Dose (tablets)* |
Under 24 | Under 2 years | ask a doctor |
24-35 | 2-3 years | 2 tablets |
36-47 | 4-5 years | 3 tablets |
48-59 | 6-8 years | 4 tablets |
60-71 | 9-10 years years | 5 tablets |
72-95 | 11 | 6 tablets |
Other Information
- store at controlled room temperature 20-25°C (68-77°F). Avoid high humidity. Protect from light
- see end flap for expiration date and lot number
Inactive Ingredients
citric acid, corn starch, crospovidone, D&C red 30 aluminum lake, dextrose, ethylcellulose, FD&C blue 1 aluminum lake, flavors, gelatin, maltodextrin, magnesium stearate, sucralose
Questions Or Comments?
1-866-467-2748
Product Packaging
NDC 68016-196-00
Compare to Children's Tylenol® Meltaways® Active Ingredient*
Premier Value
Children's
Pain Reliever
Ages 2-6
ACETAMINOPHEN
pain reliever/fever reducer
Aspirin Free/ Ibuprofen Free
GRAPE FLAVOR
30 count – 80mg each
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children's Tylenol® Meltaways®.
Premier Value Children's Pain Reliever (080gr30pvfc Ol)
* Please review the disclaimer below.
