FDA Label for Pain Reliever Extra Strength
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH CAPLET)
- 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
- PRODUCT LABEL
Pain Reliever Extra Strength Product Label
The following document was submitted to the FDA by the labeler of this product Equate (wal-mart Stores, Inc.) (see Also Wal-mart 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 Ingredient (In Each Caplet)
Acetaminophen 500 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to
- headache
- the common cold
- backache
- minor arthritis pain
- toothache
- muscular aches
- premenstrual and menstrual cramps
- temporarily reduces fever
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 ever 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 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
- 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.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
Overdose warning: 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)
- adults and children 12 years and over
- take 2 caplets every 6 hours while symptoms last
- do not take more than 6 caplets in 24 hours
- do not take for more than 10 days unless directed by a doctor
- children under 12 years: do not use
Other Information
- store between 20-25°C (68-77°F)
Inactive Ingredients
corn starch, croscarmellose sodium*, hypromellose*, lactose monohydrate*, magnesium stearate*, maltodextrin*, medium-chain triglycerides*, mineral oil*, polydextrose*, polyethylene glycol*, polyvinyl alcohol*, povidone, purified water*, sodium starch glycolate*, stearic acid*, talc*, titanium dioxide
*contains one or more of these ingredients
Questions Or Comments?
Call 1-888-287-1915
Principal Display Panel
Compare to Tylenol® Extra Strength Active Ingredient†
Extra Strength
Pain Reliever
Acetaminophen 500 mg
Pain reliever/Fever reducer
Caplets
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
†This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol® Extra Strength.
Distributed by:
Wal-Mart Stores, Inc.,
Bentonville, AR 72716
Product Label
Equate Acetaminophen 500 mg Caplet
* Please review the disclaimer below.