FDA Label for Pain Reliever
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- 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.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Pain Reliever Product Label
The following document was submitted to the FDA by the labeler of this product L.n.k. International, Inc.. 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
Acetaminophen 500 mg
Purpose
Pain reliever/fever reducer
Uses
For the temporary relief of minor aches and pains associated with
- headache
- toothache
- minor arthritis pain
- muscular aches
- the common cold
- menstrual cramps
For the reduction of fever.
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 maximum daily amount
- with other drugs containing acetaminophen
- 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.
- for more than 10 days for pain unless directed by a doctor
- for more than 3 days for fever unless directed by a doctor
Ask A Doctor Before Use If You Have
- liver disease
Ask A Doctor Or Pharmacist Before Use If You Are
- you are taking the blood thinning drug warfarin
Stop Use And Ask A Doctor If
- symptoms do not improve
- new symptoms occur
- pain or fever persists or gets worse
- redness or swelling is present
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 use more than directed
Adults and children 12 years and over: | Take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours. |
Children under 12 years: | Do not give this adult strength product to children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage. |
Other Information
- store at room temperature 59 ̊-86 ̊F (15 ̊-30 ̊C)
- tamper-evident sealed packets
- do not use any opened or torn packets
Inactive Ingredients
corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized starch*, sodium starch glycolate*, stearic acid, titanium dioxide*
*may contain
Questions Or Comments?
1-800-426-9391
Principal Display Panel
QUALITY
PLUS†
NDC 50844-270-24
†Compare to active ingredient in Extra Strength Tylenol®
EXTRA STRENGTH
PAIN RELIEVER
Acetaminophen 500 mg
PAIN RELIEVER/FEVER REDUCER
CONTAINS NO ASPIRIN
60 Packets
of 2 Tablets each
500 mg each
ACTUAL SIZE
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED
OR IF PACKET IS TORN, BROKEN OR SHOWS ANY SIGNS
OF TAMPERING
†This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Extra Strength Tylenol®.
50844 ORG
Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive Hauppauge, NY 11788 USA
* Please review the disclaimer below.