OTC Medication Information: Sunmark Arthritis 8 Hour

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

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 over 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
    children under 12 years do 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

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.
(click image for full-size original)
SUNMARK ARTHRITIS 8 HOUR
acetaminophen tablet, film coated, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-924
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 650 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
STARCH, PREGELATINIZED CORN
PROPYLENE GLYCOL
SODIUM LAURYL SULFATE
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape OVAL (Capsule shaped) Size 19mm
Flavor Imprint Code cor116
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49348-924-09 50 TABLET, FILM COATED, EXTENDED RELEASE (TABLET) in 1 BOTTLE None
2 NDC:49348-924-10 100 TABLET, FILM COATED, EXTENDED RELEASE (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076200 04/30/2002
Labeler — Sunmark (177667227)
Registrant — Ohm Laboratories Inc. (051565745)
Establishment
Name Address ID/FEI Operations
Ohm Laboratories Inc. 184769029 manufacture (49348-924)

Revised: 08/2012 Sunmark

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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