Drug Facts
Active ingredient (in each tablet)
Acetaminophen 500 mg
Acetaminophen Tablet
FDA Label NDC 0536-1172
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rugby Laboratories for the product Acetaminophen (NDC 0536-1172). 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 drug facts, purpose, uses, warnings, do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, 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 reduces fever and relieves minor aches and pains caused by
• headache
• muscular aches
• common cold
• toothache
• backache
• minor pain of arthritis
• premenstrual and menstrual cramps
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
• more than 4,000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash 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
Otc - Ask Doctor
Ask a doctor before use if you have liver disease
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Otc - Stop Use
Stop use and ask a doctor if
• pain gets worse or lasts more than 10 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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose Warning:
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick 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 (see overdose warning)
adults and children 12 years and over:
• take 2 tablets every 6 hours while symptoms last
• do not take more than 6 tablets in 24 hours, unless directed by a doctor
• do not take for more than 10 days unless directed by a doctor
children under 12 years: ask a doctor
Other Information
store at room temperature
Inactive Ingredient
Povidone, pregelatinized starch, sodium starch glycolate, stearic acid
Questions Or Comments?
Call 1-800-645-2158
Other
This is a bulk package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*Rugby Laboratories is not affiliated with the owner of the registered trademark Tylenol®.
Distributed by: Rugby Laboratories
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152 USA
www.rugbylaboratories.com
Re-order No. 370596
Package Label.Principal Display Panel
Rugby
THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN
COMPARE TO THE ACTIVE INGREDIENT IN EXTRA STRENGTH TYLENOL®*
NDC 0536-1172-10
See New Warnings Information & Directions
Extra Strength Acetaminophen
Pain Reliever/Fever Reducer
Aspirin Free
1000 Tablets 500mg each
5427-label (5427 1000g Label)
* Please review the disclaimer below.
