Drug Facts
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Extra Strength Acetaminophen Tablet, Coated
FDA Label NDC 85828-341
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Grocery Outlet, Inc. for the product Extra Strength Acetaminophen (NDC 85828-341). 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, 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Caplet)
Acetaminophen 500 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- temporarily reduces fever
-the common cold
-headache
-backache
-minor pain of arthritis
-toothache
-muscular aches
-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
- 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.
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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 caplets every 6 hours while symptoms last
- do not take more than 6 caplets in 24 hours, unless directed by a doctor
- do not take for more than 10 days unless directed by a doctor
| adults and children 12 years and over | |
| children under 12 years | ask a doctor |
Other Information
- SODIUM FREE
- store between 20-25°C (68-77°F) excursions permitted between 15-30°C (59-86°F)
- use by expiration date on package
Inactive Ingredients
hypromellose, mineral oil, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid, titanium dioxide
*may contain this ingredient
Questions Or Comments?
Call 1-877-290-4008
Package Label.Principal Display Panel
Label-acetaminophen-200s (Label Acetaminophen 200s)
* Please review the disclaimer below.
