Active Ingredient (In Each Tablet)
Acetaminophen 325 mg
Pain Relief Tablet
FDA Label NDC 11822-0104
15 label sections · Submitted to the FDA by Rite Aid Corporation · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Pain Relief (NDC 11822-0104). 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 the user has, ask a doctor or pharmacist before use if the user is, stop use and ask a doctor if, 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
- headache
- backache
- minor pain of arthritis
- toothache
- muscular aches
- premenstrual and menstrual cramps
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 4,000 mg of acetaminophen in 24 hours
- child takes more than 5 doses in 24 hours
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
- 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.
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 you are allergic to acetaminophen or any of the inactive ingredients in this product
Ask A Doctor Before Use If The User Has
liver disease.
Ask A Doctor Or Pharmacist Before Use If The User Is
taking the blood thinning drug warfarin.
Stop Use And Ask A Doctor If
- pain gets worse or lasts more than 10 days in adults
- redness or swelling is present
- pain gets worse or lasts more than 5 days in children under 12 years
- new symptoms occur
- fever gets worse or lasts more than 3 days
These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of accidental overdose, get medical help or contact a Poison Control Center 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
- do not take more than directed
- take 2 tablets every 4 to 6 hours while symptoms last
- do not take more than 10 tablets in 24 hours
- do not take for more than 10 days unless directed by a doctor
- take 1 tablet every 4 to 6 hours while symptoms last
- do not take more than 5 tablets in 24 hours
- do not take for more than 5 days unless directed by a doctor
| adults and children 12 years and over | |
| children 6-11 years | |
| children under 6 years | ask a doctor |
Other Information
- 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
corn starch, povidone, sodium starch glycolate, stearic acid
Questions Or Comments?
1-800-426-9391
Principal Display Panel
NDC 11822-0104-1
Compare to the active ingredient of Regular Strength Tylenol®*
REGULAR STRENGTH
PAIN RELIEF
ACETAMINOPHEN
ACETAMINOPHEN 325 mg
PAIN RELIEVER/FEVER REDUCER
RITE
AID®
PHARMACY
ACTUAL SIZE
100 TABLETS
Rite Aid 44-104 (Rite Aid 44 104 1)
* Please review the disclaimer below.
