SUNMARK ARTHRITIS 8 HOUR- acetaminophen tablet, film coated, extended release 
Sunmark

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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

Keep the carton. It contains important information.

Contains No Aspirin.

Distributed By McKesson

One Post Street, San Francisco, CA 94104

www.sunmarkbrand.com

PRINCIPAL DISPLAY PANEL

sunmark®

NDC 49348-924-09

See New Warnings Information

Lasts up to 8 hour

8 hour pain relief

Acetaminophen Extended-Release Tablets, USP 650 mg

Pain Reliever/Fever Reducer

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

Use only as directed.

50 CAPLETS*650 mg EACH

(*capsule-shaped tablets)

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

COMPARE TO TYLENOL®8 HOUR ACTIVE INGREDIENT

This product is not manufactured or distributed by McNeil Consumer Healthcare, Inc. The owner of the registered trademark Tylenol®is The Tylenol Company.

This is the 50 count bottle carton label for Sunmark Acetaminophen extended-release tablets, USP 650 mg.
SUNMARK ARTHRITIS 8 HOUR 
acetaminophen tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-924
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScoreno score
ShapeOVAL (Capsule shaped) Size19mm
FlavorImprint Code cor116
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49348-924-0950 in 1 BOTTLE
2NDC:49348-924-10100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07620004/30/2002
Labeler - Sunmark (177667227)
Registrant - Ohm Laboratories Inc. (051565745)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.184769029manufacture(49348-924)

Revised: 8/2012
Document Id: 579c5e78-3a1a-4b93-b1ad-3d71d83c91f7
Set id: ab6401f9-9310-40dd-8f15-0d7199e27925
Version: 1
Effective Time: 20120816
 
Sunmark