Active Ingredient
Acetaminophen
Acetaminophen
FDA Label NDC 42254-155
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rebel Distributors Corp for the product Acetaminophen (NDC 42254-155). 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, purpose, keep out of reach of children, uses, warnings, directions, package/label principal display panel, 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
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical, even if you do not notice any signs or symptoms.
Uses
temporarily reduces fever and relieves minor aches and pains caused by
headache
common cold
flu
toothache
sore throat
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if the 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, lasts for more than 2 days or is accompanied or fillowed 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.
Ask a doctor before use if the child has liver disease
Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin.
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
redness or swelling is present
any new symptoms appear
Directions
this product does not contain directions or complete warnings for adult use
find correct does on chart below
if possible, use weight to dose, otherwise use age
chew tablets before swallowing
give dose every 4 hours while symptoms last
do not give more than 5 doses in 24 hours
| Weight (pounds) | Age (years) | Dose (tablets) |
| 72 - 95 | 11 - 12 | 4 - 6 |
| 60 - 71 | 9 - 10 | 4 - 5 |
| 48 - 59 | 6 - 8 | 4 |
| 36 - 47 | 4 - 5 | 3 |
| 24 - 35 | 2 - 3 | 2 |
| under 24 | under 2 | ask a doctor |
Package/Label Principal Display Panel
Acetaminophen 80mg (5c0dbae2 328b 42b6 A8b6 55009f3c78e5 01)
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