Topcare 8 Hour Pain Relief

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

Topco 8 Hour Pain Relief Drug Facts

Active ingredient (in each caplet)

Acetaminophen 650 mg

Purpose

Pain reliever/fever reducer

Slideshow: Are You at Risk of Prescription Drug Addiction?

Uses

  • temporarily relieves minor aches and pains due to:
  • muscular aches
  • backache
  • headache
  • toothache
  • the common cold
  • menstrual cramps
  • minor pain of arthritis
  • 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 for 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 and children 12 years and over
  • 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
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 lot number and expiration date

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C red #40 aluminum lake, 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

For up to 8 hour relief of minor muscle aches & pain

8 Hour Pain Relief

Acetaminophen Extended-Release Tablets, 650 mg

Pain Reliever / Fever Reducer

Actual Size

Compare to Tylenol® 8 Hour active ingredient

†Capsule-Shaped Tablets

8 Hour Pain Relief Carton


TOPCARE 8 HOUR PAIN RELIEF 
acetaminophen tablet, film coated, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-217
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 650 mg
Product Characteristics
Color RED Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code L217
Contains         
Packaging
# Item Code Package Description
1 NDC:36800-217-78 1 BOTTLE (BOTTLE) in 1 CARTON
1 100 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 11/29/2005
Labeler - Topco Associates LLC (006935977)
Revised: 01/2010
 
Topco Associates LLC



Hide
(web2)