Active Ingredient (In Each Tablet)
Acetaminophen 160 mg
Junior Acetaminophen Tablet, Orally Disintegrating
FDA Label NDC 68016-198
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 Junior Acetaminophen (NDC 68016-198). 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
- flu
- headache
- 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
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 (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: 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 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 below. If possible, use weight to dose; otherwise use age.
- if needed, repeat dose every 4 hours while symptoms last
- dissolve in mouth or chew before swallowing
- if needed, 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) | Tablets |
under 48 | under 6 years | Ask a doctor |
48-59 | 6-8 years | 2 |
60-71 | 9-10 years | 2 1/2 |
72-95 | 11 years | 3 |
96 and over | 12 years | 4 |
Other Information
- store at between 20°C-25°C (68°F-77°F). Avoid high humidity
- see end flap for expiration date and lot number
Inactive Ingredients
citric acid, corn starch, crospovidone, D&C red no. 30 aluminum lake, dextrose, ethylcellulose, FD&C blue no. 1 aluminum lake, flavors, gelatin, maltodextrin, magnesium stearate, sucralose
Principal Display Panel
Compare to Jr. Strength Tylenol® Meltaways® Active Ingredient*
Premier Value
Junior
Pain Reliever
Ages 6-11
ACETAMINOPHEN
Pain Reliever/Fever Reducer
Aspirin-Free
Ibuprofen-Free
SEE NEW WARNINGS INFORMATION
Grape Flavor
24 COUNT - 160 mg each
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
Distributed by
Chain Drug Consortium, LLC.
3301 N.W. Boca Raton Blvd.,
Suite 101, Boca Raton FL 33431
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Junior Strength Tylenol® Meltaways®.
Premier Value Junior Pain Reliever 24ct (160gr24pvfc)
* Please review the disclaimer below.
