Label: ARTHRITIS PAIN RELIEVER- acetaminophen tablet, film coated, extended release
- NDC Code(s): 70677-1130-1
- Packager: Strategic Sourcing Services
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 8, 2023
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- 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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PRINCIPAL DISPLAY PANEL - 650 mg Caplet Bottle Carton
Foster & Thrive TM
EASY TO OPEN BOTTLE
COMPARE TO TYLENOL ®ARTHRITIS PAIN ACTIVE INGREDIENT
NDC 70677-1130-1arthritis pain reliever
Acetaminophen Extended-release Tablets USP, 650 mg
Pain Reliever/Fever Reducer
For the Temporary Relief of Minor Arthritis Pain
THIS PACKAGE FOR HOUSEHOLDS
WITHOUT YOUNG CHILDRENLASTS UP TO 8 HOURS
Use only as directed.
100 CAPLETS* 650 mg EACH
(*capsule-shaped tablets)DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN
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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:70677-1130 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 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70677-1130-1 1 in 1 CARTON 12/08/2023 1 100 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 - Strategic Sourcing Services (116956644) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 184769029 manufacture(70677-1130)