Label: ACETAMINOPHEN EXTENDED RELEASE- acetaminophen tablet
- NDC Code(s): 41163-669-10, 41163-669-50
- Packager: EQUALINE (SuperValu)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 7, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each caplet)
- Purpose
- Uses
-
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 6 caplets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks ever day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek a 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
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
compare Tylenol® 8HR Arthritis Pain active ingredient†
extended-release
arthritis pain reliever
acetaminophen 650 mg
pain reliever/fever reducer
for the temporary relief of minor arthritis pain
caplets* (*capsule-shaped bi-layer tablets)
†This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol® 8 HR Arthritis Pain.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY: SUPERVALU INC., EDEN PRAIRIE, MN 55344 USA
- Product Label
-
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN EXTENDED RELEASE
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-669 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) SODIUM LAURYL SULFATE (UNII: 368GB5141J) Product Characteristics Color white Score no score Shape CAPSULE Size 19mm Flavor Imprint Code 511 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41163-669-50 1 in 1 BOX 09/30/2019 1 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:41163-669-10 1 in 1 BOX 09/30/2019 2 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207035 09/30/2019 Labeler - EQUALINE (SuperValu) (006961411)