Topcare 8 Hour Pain Relief

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

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

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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 NDC Product Code (Source) 36800-217 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 No Inactive Ingredients Found

Product Characteristics Color RED Score no score Shape CAPSULE Size 19mm Flavor Imprint Code L217 Contains

Packaging # NDC Package Description Multilevel Packaging 1 36800-217-78 1 BOTTLE In 1 CARTON contains a BOTTLE 1 100 TABLET In 1 BOTTLE This package is contained within the CARTON (36800-217-78)

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: 01/2010Topco Associates LLC

More Topcare 8 Hour Pain Relief resources

• Topcare 8 Hour Pain Relief Side Effects (in more detail)
• Topcare 8 Hour Pain Relief Dosage
• Topcare 8 Hour Pain Relief Use in Pregnancy & Breastfeeding
• Topcare 8 Hour Pain Relief Drug Interactions
• 0 Reviews for Topcare 8 Hour Pain Relief - Add your own review/rating

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