Label: ARTHRITIS PAIN RELIEVER- acetaminophen tablet, film coated, extended release
- NDC Code(s): 51660-333-01, 51660-333-24, 51660-333-50
- Packager: Ohm Laboratories Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 4, 2021
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- 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
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- more than 6 caplets in 24 hours, which is the maximum daily amount
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
Allergy alert
acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
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- blisters
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- rash
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- if you are allergic to acetaminophen or any of the inactive ingredients in this product.
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Directions
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- do not take more than directed (see overdose warning)
adults
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- take 2 caplets every 8 hours with water
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- swallow whole; do not crush, chew, split or dissolve
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- do not take more than 6 caplets in 24 hours
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- do not use for more than 10 days unless directed by a doctor
under 18 years of age
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- ask a doctor
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 650 mg CAPLET Bottle Carton
NDC 51660-333-50
†Compare To the active ingredient of Tylenol® Arthritis Pain
Ohm®
Last up to 8 HoursUse only as directed.
Arthritis Pain Relief
Acetaminophen
Extended-release Tablets USP, 650 mg
Pain Reliever/Fever Reducer- •
- For the Temporary Relief of Minor Arthritis Pain
DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN50 CAPLETS* (*Capsule-Shaped Tablets)
-
Package/Label Principal Display Panel
NDC 51660-333-01
†Compare To the active ingredient of Tylenol® Arthritis Pain
Ohm®
Last up to 8 HoursUse only as directed.
Arthritis Pain Relief
Acetaminophen
Extended-release Tablets USP, 650 mg
Pain Reliever/Fever Reducer- •
- For the Temporary Relief of Minor Arthritis Pain
DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN100 CAPLETS* (*Capsule-Shaped Tablets)
-
Principal Display Panel
NDC 51660-333-24
†Compare To the active ingredient of Tylenol® Arthritis Pain
Ohm®
Last up to 8 HoursUse only as directed.
Arthritis Pain Relief
Acetaminophen
Extended-release Tablets USP, 650 mg
Pain Reliever/Fever Reducer- •
- For the Temporary Relief of Minor Arthritis Pain
DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN24 CAPLETS* (*Capsule-Shaped Tablets)
-
INGREDIENTS AND APPEARANCE
ARTHRITIS PAIN RELIEVER
acetaminophen tablet, film coated, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) 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:51660-333-01 1 in 1 CARTON 04/30/2002 1 100 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:51660-333-50 1 in 1 CARTON 04/30/2002 2 50 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:51660-333-24 1 in 1 CARTON 09/03/2021 3 24 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076200 04/30/2002 Labeler - Ohm Laboratories Inc. (184769029) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 184769029 MANUFACTURE(51660-333)