Label: ARTHRITIS PAIN RELIEVER- acetaminophen tablet, film coated, extended release
- NDC Code(s): 50268-052-11, 50268-052-15
- Packager: AvPAK
- This is a repackaged label.
- Source NDC Code(s): 51660-333
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 9, 2024
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- 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 every 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 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?
-
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 50268-052-15
Acetaminophen Extended-release Tablets USP
Arthritis Pain Relief
650 mg
50 Tablets (5 X 10) Unit Dose
NDC 50268-052-15
Acetaminophen Extended-release Tablets USP
Arthritis Pain Relief
650 mg
50 Tablets (5 X 10) Unit Dose
DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN.
Use only as directed.
Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Mfg. Rev. R0315 AV 02/16 (P)
AvPAK
A PRODUCT OF AvKARE
-
INGREDIENTS AND APPEARANCE
ARTHRITIS PAIN RELIEVER
acetaminophen tablet, film coated, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50268-052(NDC:51660-333) 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STARCH, CORN (UNII: O8232NY3SJ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) Product Characteristics Color white Score no score Shape OVAL Size 19mm Flavor Imprint Code cor116 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50268-052-15 50 in 1 BOX, UNIT-DOSE 03/07/2016 1 NDC:50268-052-11 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076200 03/07/2016 Labeler - AvPAK (832926666)