FDA Label for Non-aspirin
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH TABLET)
- PURPOSE
- WARNINGS
- LIVER WARNING:
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING
- KEEP OUT OF REACH OF CHILDREN.
- OVERDOSE WARNING:
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
- USES
Non-aspirin Product Label
The following document was submitted to the FDA by the labeler of this product Etex Pharm Co., Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients (In Each Tablet)
Acetaminophen 500mg
Purpose
Pain Reliever/fever reducer
Warnings
Liver Warning:
this product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 tablets in 24 hours, which is the maxium daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
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 You Have
liver disease
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin
Stop Use And Ask A Doctor If
- new symptoms occur
- redness or swelling is present
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days These could be sign of a serious condition
If Pregnant Or Breast-Feeding
ask a health professional before use.
Keep Out Of Reach Of Children.
Enter section text here
Overdose Warning:
Taking more than the recommended dose(overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. 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)
- take 2 tablets every 4 to 6 hours as needed
- do not take more than 8 tablets in 24 hours
- do not use for more than 10 days unless directed by a doctor
adults and children 12 years and over | |
children under 12 years | do not use this adult Extra Strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage |
Other Information
- do not use if imprinted safety seal under cap is broken or missing.
- store between 20-25°C (68-77°F)
- see end panel for lot number and expiration date
Inactive Ingredients
benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, and sodium chloride
Package Label.Principal Display Panel
non-aspirin 50 tablet
Uses
temporarily relieves minor aches and pains due to:
- headache
- muscular aches
- backache
- arthritis
- the common cold
- toothache
- menstrual cramps
- temporarily reduces fever
* Please review the disclaimer below.