ACETAMINOPHEN- acetaminophen tablet, film coated, extended release 
Fred's Inc.

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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 1-800-406-7984

PRINCIPAL DISPLAY PANEL

fred's®

Use only as directed.

See New Warnings Information

LASTS UP TO 8 HOURS

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 ACETAMINOPHEN

50 CAPLETS*650 mg EACH (*capsule-shaped tablets)

Compare To Active Ingredient of Tylenol®Arthritis Pain

DISTRIBUTED BY: fred's, Inc.

5095092/R0512

This is the 50 count bottle carton label for Fred's Acetaminophen extended-release tablets, USP 650 mg.
ACETAMINOPHEN 
acetaminophen tablet, film coated, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55315-333
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:55315-333-50 50 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076200 04/30/2004
Labeler - Fred's Inc. (005866116)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
Name Address ID/FEI Business Operations
Ohm Laboratories Inc. 184769029 manufacture(55315-333)

Revised: 1/2013
Document Id: 4f70b3db-763c-4719-8111-c0aec85b2c9b
Set id: 070569ec-82b1-4b26-b38b-3fb3caf71f19
Version: 1
Effective Time: 20130109
 
Fred's Inc.