Active Ingredient(S)
Acetaminophen 160 mg
Children Pain Relief Tablet, Chewable
FDA Label NDC 69168-440
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Children Pain Relief (NDC 69168-440). 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(s), purpose, use(s), warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if, 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
Use(S)
- 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 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 symptoms.
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 doctor
| Weight (lb) | Age (yr) | Dose (chewable tablets)** |
| Under 24 | Under 2 | Ask a doctor |
| 24-35 | 2-3 | 1 tablet |
| 36-47 | 4-5 | 1 1/2 tablets |
| 48-59 | 6-8 | 2 tablets |
| 60-71 | 9-10 | 2 1/2 tablets |
| 72-95 | 11 | 3 tablets |
**or as directed by a doctor
Other Information
- TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients
citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake,
dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol,
polyethylene, stearic acid, sucralose
Questions/Comments
Call 1-888-952-0050 Monday through Friday 9AM - 5PM EST
Principal Display Panel
Acetaminophen 160mg (440 Children Pain Relief 1)
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