ACETAMINOPHEN- acetaminophen tablet, extended release 
Cardinal Health

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Drug Facts

ACTIVE INGREDIENT (IN EACH GELTAB)

Acetaminophen USP, 650 mg

PURPOSE

Pain reliever/fever reducer

USES

WARNINGS

Liver warning: This product contains acetaminophen. Sever 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 have difficulty swallowing large tablets or capsules. People over 65 may have difficulty swallowing these tablets.
  • 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
  • the tablet got stuck in your throat

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, gelatin, glycerin, hypromellose, iron oxide black, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, starch, titanium dioxide

QUESTIONS?

Call 1-800-406-7984

PRINCIPAL DISPLAY PANEL

NDC 37205-662-58

LEADER®

Compare to Tylenol Arthritis Pain active ingredient

Use only as directed.

Lasts up to 8 hours

Arthritis Pain Reliever

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 ACETAMINOPHEN

40 GELTABS*650 mg EACH

*Gelatin-Coated Tablets

DISTRIBUTED BY CARDINAL HEALTH

5099022/1012

This is the 40 count bottle carton label for Leader Acetaminophen extended-release tablets, USP 650 mg (geltabs).
ACETAMINOPHEN 
acetaminophen tablet, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-662
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)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color white (White to Yellow) Score no score
Shape ROUND Size 13mm
Flavor Imprint Code 350
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:37205-662-58 40 in 1 BOTTLE
2 NDC:37205-662-57 80 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078569 12/21/2012
Labeler - Cardinal Health (097537435)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
Name Address ID/FEI Business Operations
Ohm Laboratories Inc. 184769029 manufacture(37205-662)

Revised: 1/2013
Document Id: bc9938dd-9ee4-49c2-a80e-bc90d0ca6646
Set id: a05a93b7-e132-4289-9d58-c1a6b9c1c1d6
Version: 1
Effective Time: 20130116
 
Cardinal Health