ACETAMINOPHEN- acetaminophen tablet, film coated, extended release 
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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 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

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

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

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

select brand®

NDC 15127-332-24

Use only as directed.

ARTHRITIS PAIN RELIEF

See New Warnings Information

Non-Aspirin

AcetaminophenCaplets*650 mg Extended-Release Tablets, USP

24 Caplets* 650 mg each (*capsule-shaped tablets)

Pain Reliever/Fever Reducer

For the Temporary Relief of Minor Arthritis Pain

Lasts up to 8 hours

٭Compare to the active ingredient of TYLENOL®ARTHRITIS PAIN

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

Distributed by: SELECT BRAND DISTRIBUTORS

5095101/R0412

This is the 24 count blister carton label for Select Brand 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:15127-332
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:15127-332-24 24 in 1 BOTTLE
2 NDC:15127-332-01 100 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076200 04/30/2002
Labeler - Select Brand (043562370)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
Name Address ID/FEI Business Operations
Ohm Laboratories Inc. 184769029 manufacture(15127-332)

Revised: 10/2012
Document Id: 52cde4d1-9930-4d53-9c28-2dcc281867d2
Set id: 80310ab1-f10f-4881-b31a-fa156db8e474
Version: 1
Effective Time: 20121002
 
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