TOPCO ARTHRITIS 8 HOUR - acetaminophen tablet, film coated, extended release 
Topco Associates LLC

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Drug Facts

ACTIVE INGREDIENT (IN EACH CAPLET)

Acetaminophen USP, 650 mg

PURPOSE

Pain reliever/fever reducer

USES

WARNINGS

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

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.

Ask a doctor before use if you have

Liver disease.

Ask a doctor or pharmacist before use if you are

Taking the blood thinning drug warfarin.

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding

Ask a health professional before use.

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

Croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide

QUESTIONS?

call 1-888-423-0139

PRINCIPAL DISPLAY PANEL

TopCare®

NDC 36800-228-01

FOR UP TO 8 HOUR RELIEF OF MINOR MUSCLE ACHES & PAIN

Lasts up to 8 - Hour

Pain Relief

ACETAMINOPHEN EXTENDED-RELEASE TABLETS, USP 650 mg

Pain Reliever/Fever Reducer

Use only as directed.

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

COMPARE TO TYLENOL®8 HOUR active ingredient††

100 CAPLETS650 mg EACH

(CAPSULE-SHAPED TABLETS)

DISTRIBUTED BY TOPCO ASSOCIATES LLC

5095195/R512

This is the 100 count bottle carton label for Topco Acetaminophen extended-release tablets, USP 650 mg.
TOPCO ARTHRITIS 8 HOUR  
acetaminophen tablet, film coated, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-228
Route of Administration ORAL DEA Schedule     
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)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color white Score no score
Shape OVAL (Capsule Shaped) Size 19mm
Flavor Imprint Code cor116
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:36800-228-01 100 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076200 04/30/2002
Labeler - Topco Associates LLC (006935977)
Registrant - Ohm Laboratories Inc. (051565745)
Establishment
Name Address ID/FEI Business Operations
Ohm Laboratories Inc. 184769029 manufacture(36800-228)

Revised: 8/2012
Document Id: c9d94bfa-83e7-4f7a-b8c3-f74addd652ee
Set id: 2c7f99d4-b0c9-4094-9969-dcb8d04717a4
Version: 1
Effective Time: 20120823
 
Topco Associates LLC