Active Ingredient (In Each Chewable Tablet)
Acetaminophen 160 mg
Kroger Children Pain Plus Fever Chewables Tablet, Chewable
FDA Label NDC 41226-061
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kroger Company for the product Kroger Children Pain Plus Fever Chewables (NDC 41226-061). 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 chewable 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▪ 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▪ skin reddening▪ blister▪ rash
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.▪ 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 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.
Keep Out Of Reach Of Children.
Overdose warning: 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)▪ chew or crush tablets completely before swallowing▪ find the right dose on chart below. If possible, use weight to dose; otherwise use age.▪ repeat dose every 4 hours while symptoms last▪ do not give more than 5 times in 24 hours
Weight (lb) | under 24 | 24-35 | 36-47 | 48-59 | 60-71 | 72-95 |
Age (yr) | under 2 years | 2-3 years | 4-5 years | 6-8 years | 9-10 years | 11 years |
Dose (Tablets) | ask a doctor | 1 tablet | 1 ½ tablets | 2 tablets | 2 ½ tablets | 3 tablets |
*or as directed by a doctor
Other Information
▪ store at room temperature. Avoid high humidity. Protect from light▪ see end flap for expiration date and lot number
Inactive Ingredients
citric acid, crospovidone, D&C Red No. 30 Lake, dextrose, FD&C Blue No. 1 Lake, flavors, hydroxypropyl cellulose, magnesium stearate, maltodextrin, silicon dioxide, sodium carboxymethyl cellulose, starch, sucralose
Questions Or Comments?
1-866-467-2748
Principal Display Panel
NDC 41226-061-24
Compare to active ingredient in Children’s Tylenol® Chewables*
Children’s Pain + Fever Chewables
ACETAMINOPHEN 160mg Per Tablet
Pain Reliever/Fever Reducer
- Aspirin free
- Ibuprofen Free
Chew or crush tablets completely before swallowing
Ages 2-11
Grape Flavor
Naturally and Artificially Flavored
24 CHEWABLE TABLETS 160 mg each
TAMPER EVIDENT:DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
IMPORTANT: Keep this carton for future reference on full labeling. |
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark children’s Tylenol® Chewable.
DIST. BY:
Kroger Children's Pain+ Fever Chewable Tablets Acetaminophen (160gr24pvfc)
* Please review the disclaimer below.
