Topcare Arthritis Pain Relief

Generic Name: acetaminophen
Dosage Form: tablet, film coated, extended release

Topco Arthritis Pain Relief Drug Facts

Active ingredient (in each caplet)

Acetaminophen 650 mg

Purpose

Pain reliever/fever reducer

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Uses

  • temporarily relieves minor aches and pains due to:
  • arthritis
  • the common cold
  • headache
  • toothache
  • muscular aches
  • backache
  • menstrual cramps
  • 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

  • if you are allergic to acetaminophen
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

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 for 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: Taking more than the recommended dose (overdose) may cause liver damage. 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
  • take 2 caplets every 8 hours with water
  • swallow whole – do not crush, chew 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

  • store at 20°-25°C (68°-77°F). Avoid excessive heat 40°C (104°F).
  • see end panel for lot number and expiration date

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol 400, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

1-888-423-0139

Principal Display Panel

See New Warnings Information

Lasts up to 8 hours

Temporary, Minor

Arthritis Pain Relief

Acetaminophen Extended-Release Tablets, 650 mg

Pain Reliever/Fever Reducer

Actual Size

Compare to Tylenol® Arthritis Pain active ingredient

†Capsule-Shaped Tablets

Arthritis Pain Relief Carton

Topcare Arthritis Pain Relief  TEMPORARY MINOR
acetaminophen tablet, film coated, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-544
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 650 mg
Product Characteristics
Color WHITE Score no score
Shape CAPSULE (caplet) Size 19mm
Flavor Imprint Code L544
Contains         
Packaging
# Item Code Package Description
1 NDC:36800-544-62 1 BOTTLE (BOTTLE) in 1 CARTON
1 24 TABLET, FILM COATED, EXTENDED RELEASE (TABLET) in 1 BOTTLE
2 NDC:36800-544-71 1 BOTTLE (BOTTLE) in 1 CARTON
2 50 TABLET, FILM COATED, EXTENDED RELEASE (TABLET) in 1 BOTTLE
3 NDC:36800-544-78 1 BOTTLE (BOTTLE) in 1 CARTON
3 100 TABLET, FILM COATED, EXTENDED RELEASE (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075077 08/04/2005
Labeler - Topco Associates LLC (006935977)
Revised: 08/2009
 
Topco Associates LLC



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