Active Ingredient (In Each Tablet)
Acetaminophen 160 mg
Pain Relief Tablet, Chewable
FDA Label NDC 46122-424
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Amerisource Bergen for the product Pain Relief (NDC 46122-424). 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:
- headache
- sore throat
- flu
- toothache
- the common cold
- 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
- blisters
- 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 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.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptom
Directions
- this product does not contain directions or complete warnings for adult use
- do not give more than directed
- find the right dose on chart below. 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 doctors.
| Weight (lb) | Age (yr) | Dose (tablets)* |
| Under 24 | Under 2 | Ask a doctor |
| 24-35 | 2-3 | 2 |
| 36-47 | 4-5 | 1 1/2 |
| 48-59 | 6-8 | 2 |
| 60-71 | 9-10 | 2 1/2 |
| 72-95 | 11 | 3 |
* or as directed by a doctor
Other Information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- avoid high humidity
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive Ingredients
citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, flavor, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose
Questions Or Comments?
1-800-426-9391
Principal Display Panel
GOOD NEIGHBOR PHARMACY®
Compare to Children's Tylenol®
active ingredient**
NDC 46122-424-62
For Ages 2-11
CHILDREN'S
Pain Relief
acetaminophen 160 mg
Pain Reliever/Fever Reducer
•aspirin free
•ibuprofen free
Bubblegum Flavor
Chewables
24 Tablets ι 160 mg Each
Actual Size
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
**This product is not manufactured or distributed
by Johnson & Johnson Corporation, owner of the
registered trademark Children's Tylenol®.
GOOD NEIGHBOR PHARMACY BRAND PRODUCTS
SATISFACTION GUARANTEED
Distributed by
AmerisourceBergen
1300 Morris Drive
Chesterbrook, PA 19087
Questions or Concerns?
www.mygnp.com
Good Neighbor Pharmacy 44-450 (Good Neighbor Pharmacy 44 450 1)
* Please review the disclaimer below.
