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Topco Arthritis Pain Relief

Pronunciation

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

For Professionals Indications Side Effects Interactions More...

Topco Arthritis 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:
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).

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

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See New Warnings Information

Lasts up to 8 hours

Temporary, Minor

Arthritis Pain Relief

Acetaminophen Extended – Release Tablets, 650 mg

Pain Reliever/Fever Reducer

This Package for Households Without Young Children

Actual Size

Compare to Tylenol® Arthritis Pain active ingredient

†Capsule-Shaped Tablets

Arthritis Pain Relief Label

TOPCARE ARTHRITIS PAIN RELIEF
acetaminophen tablet, film coated, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-966
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	Size	19mm
Flavor		Imprint Code	L544
Contains

Packaging
#	Item Code	Package Description
1	NDC:36800-966-47	150 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	08/20/2007

Labeler - Topco Associates LLC (006935977)

Revised: 04/2010

Topco Associates LLC

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