SUNMARK ARTHRITIS 8 HOUR- acetaminophen tablet, film coated, extended release 
Bryant Ranch Prepack

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Drug Facts

ACTIVE INGREDIENT (IN EACH CAPLET)

Acetaminophen USP, 650 mg

PURPOSE

Pain reliever/fever reducer

USES

  • temporarily relieves minor aches and pains due to:
    • muscular aches
    • headache
    • minor pain of arthritis
    • backache
  • temporarily reduces fever

WARNINGS

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

  • more than 6 caplets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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

  • do not take more than directed (see overdose warning)
    adults and children 12 years and overtake 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
    children under 12 yearsdo not use

OTHER INFORMATION

  • store at 20 - 25° C (68 - 77° F). Avoid excessive heat 40° C (104° F).
  • see end panel for batch number and expiration date
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

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

HOW SUPPLIED

Product: 71335-0219

NDC: 71335-0219-1 30 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE

NDC: 71335-0219-2 100 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE

NDC: 71335-0219-3 50 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE

NDC: 71335-0219-4 60 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE

NDC: 71335-0219-5 120 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE

Acetaminophen ER 650mg Tablet

Label Image
SUNMARK ARTHRITIS 8 HOUR 
acetaminophen tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-0219(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)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STARCH, 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:71335-0219-130 in 1 BOTTLE; Type 0: Not a Combination Product04/28/201601/13/2023
2NDC:71335-0219-2100 in 1 BOTTLE; Type 0: Not a Combination Product04/28/201601/13/2023
3NDC:71335-0219-350 in 1 BOTTLE; Type 0: Not a Combination Product04/28/201601/13/2023
4NDC:71335-0219-460 in 1 BOTTLE; Type 0: Not a Combination Product04/28/201601/13/2023
5NDC:71335-0219-5120 in 1 BOTTLE; Type 0: Not a Combination Product04/28/201601/13/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07620004/30/200201/13/2023
Labeler - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(71335-0219) , RELABEL(71335-0219)

Revised: 1/2023
Document Id: 67b4eff0-c4f1-416b-a1d8-98730b81d61f
Set id: 9de3ad62-d0f6-4192-a117-f2c51e45b1e7
Version: 6
Effective Time: 20230113
 
Bryant Ranch Prepack