FDA Label for Acetaminophen Easy Tabs Extra Strength
View Indications, Usage & Precautions
Acetaminophen Easy Tabs Extra Strength Product Label
The following document was submitted to the FDA by the labeler of this product Winco Foods, Llc. 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.
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Drug Facts
Active Ingredient (In Each Tablet)
Acetaminophen 500 mg
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
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
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
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.
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)
- take 2 tablets every 6 hours while symptoms last
- swallow whole – do not crush, chew, or dissolve
- do not take more than 6 tablets in 24 hours, unless directed by a doctor
- do not use for more than 10 days unless directed by a doctor
- ask a doctor
| adults and children 12 years and over | |
| children under 12 years |
Other Information
- store between 20-25°C (68-77°F)
- retain carton for complete product information
Inactive Ingredients
acesulfame potassium, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide
Questions?
Or to report an adverse event call 800-824-1706 Monday - Friday 9am - 4pm MST
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WinCo™ Foods
*Compare to the active ingredient in TYLENOL® Extra Strength EZ Tabs
EXTRA STRENGTH
Acetaminophen Easy Tabs
Sweet Coated, Easy to Swallow
PAIN RELIEVER - FEVER REDUCER
50 Tablets
500 mg EACH
* Please review the disclaimer below.