Label: ARTHRITIS PAIN RELIEVER- acetaminophen tablet, film coated, extended release
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NDC Code(s):
71335-0524-1,
71335-0524-2,
71335-0524-3,
71335-0524-4, view more71335-0524-5, 71335-0524-6
- Packager: Bryant Ranch Prepack
- 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 16, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each caplet)
- Purpose
- Uses
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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.
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Directions
- do not take more than directed (see overdose warning)
adults
- take 2 caplets every 8 hours with water
- swallow whole; do not crush, chew, split or dissolve
- do not take more than 6 caplets in 24 hours
- do not use for more than 10 days unless directed by a doctor
under 18 years of age
- ask a doctor
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
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HOW SUPPLIED
NDC: 71335-0524-1: 30 Tablets in a BOTTLE
NDC: 71335-0524-2: 100 Tablets in a BOTTLE
NDC: 71335-0524-3: 50 Tablets in a BOTTLE
NDC: 71335-0524-4: 60 Tablets in a BOTTLE
NDC: 71335-0524-6: 19 Tablets in a BOTTLE
NDC: 71335-0524-5: 120 Tablets in a BOTTLE
Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504 - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ARTHRITIS PAIN RELIEVER
acetaminophen tablet, film coated, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71335-0524(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 HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (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) CROSPOVIDONE (UNII: 2S7830E561) 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:71335-0524-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/23/2022 2 NDC:71335-0524-2 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/23/2022 3 NDC:71335-0524-3 50 in 1 BOTTLE; Type 0: Not a Combination Product 02/23/2022 4 NDC:71335-0524-4 60 in 1 BOTTLE; Type 0: Not a Combination Product 02/23/2022 5 NDC:71335-0524-6 19 in 1 BOTTLE; Type 0: Not a Combination Product 02/23/2022 6 NDC:71335-0524-5 120 in 1 BOTTLE; Type 0: Not a Combination Product 02/23/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076200 04/30/2002 Labeler - Bryant Ranch Prepack (171714327) Registrant - Bryant Ranch Prepack (171714327) Establishment Name Address ID/FEI Business Operations Bryant Ranch Prepack 171714327 repack(71335-0524) , relabel(71335-0524)