DailyMed - TOPCARE IBUPROFEN- ibuprofen tablet, film coated

NDC Code(s): 36800-604-62, 36800-604-71, 36800-604-76, 36800-604-78, view more
36800-604-82, 36800-604-85, 36800-604-90, 36800-604-93
Packager: Topco Associates LLC

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 8, 2025

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Active ingredient (in each tablet)
Ibuprofen 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug
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Purposes
Pain reliever/fever reducer

Pain reliever/fever reducer
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Uses
• temporarily relieves minor aches and pains due to: • headache • muscular aches • minor pain of arthritis - • toothache - • backache • the common cold - • menstrual cramps - • temporarily ...

•

temporarily relieves minor aches and pains due to:

•

headache

•

muscular aches

•

minor pain of arthritis

•

toothache

•

backache

•

the common cold

•

menstrual cramps

•

temporarily reduces fever

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Warnings
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: • hives - • facial swelling - • asthma (wheezing) • shock - • skin ...

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.

Symptoms may include:

•

hives

•

facial swelling

•

asthma (wheezing)

•

shock

•

skin reddening

•

rash

•

blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

•

are age 60 or older

•

have had stomach ulcers or bleeding problems

•

take a blood thinning (anticoagulant) or steroid drug

•

take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]

•

have 3 or more alcoholic drinks every day while using this product

•

take more or for a longer time than directed

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do not use

•

if you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer

•

right before or after heart surgery

Ask a doctor before use if

•

you have problems or serious side effects from taking pain relievers or fever reducers

•

the stomach bleeding warning applies to you

•

you have a history of stomach problems, such as heartburn

•

you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke

•

you are taking a diuretic

Ask a doctor or pharmacist before use if you are

•

taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin

•

under a doctor’s care for any serious condition

•

taking any other drug

When using this product

take with food or milk if stomach upset occurs

Stop use and ask a doctor if

•

you experience any of the following signs of stomach bleeding:

•

feel faint

•

vomit blood

•

have bloody or black stools

•

have stomach pain that does not get better

•

you have symptoms of heart problems or stroke:

•

chest pain

•

trouble breathing

•

weakness in one part or side of body

•

slurred speech

•

leg swelling

•

pain gets worse or lasts more than 10 days

•

fever gets worse or lasts more than 3 days

•

redness or swelling is present in the painful area

•

any new symptoms appear

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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Directions
• do not take more than directed • the smallest effective dose should be used - Adults and children 12 years and older: • take 1 tablet every 4 to 6 hours while symptoms persist - • if pain ...

•

do not take more than directed

•

the smallest effective dose should be used

Adults and children 12 years and older:

•

take 1 tablet every 4 to 6 hours while symptoms persist

•

if pain or fever does not respond to 1 tablet, 2 tablets may be used

•

do not exceed 6 tablets in 24 hours, unless directed by a doctor

Children under 12 years: ask a doctor

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Other information
• read all warnings and directions before use - • store at 20-25°C (68-77°F) • avoid high humidity and excessive heat above 40°C (104°F) • see end panel for lot number and expiration date

•

read all warnings and directions before use

•

store at 20-25°C (68-77°F)

•

avoid high humidity and excessive heat above 40°C (104°F)

•

see end panel for lot number and expiration date

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Inactive ingredients
colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, polysorbate 80, stearic acid ...

colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, polysorbate 80, stearic acid, titanium dioxide
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Questions or comments?
1-888-423-0139

1-888-423-0139
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Principal Display Panel
TopCare® health - COMPARE TO ADVIL® ACTIVE INGREDIENT - Ibuprofen Tablets, 200 mg - PAIN RELIEVER • FEVER REDUCER (NSAID) actual size - 24 COATED TABLETS

TopCare® health

COMPARE TO ADVIL® ACTIVE INGREDIENT

Ibuprofen Tablets, 200 mg

PAIN RELIEVER • FEVER REDUCER (NSAID)

actual size

24 COATED TABLETS

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INGREDIENTS AND APPEARANCE

Product Information

TOPCARE IBUPROFEN ibuprofen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-604
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BROWN	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	I2
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:36800-604-62	1 in 1 CARTON	06/15/1991
1		24 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:36800-604-71	1 in 1 CARTON	02/15/1988
2		50 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:36800-604-78	1 in 1 CARTON	03/15/1988
3		100 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:36800-604-85	1 in 1 CARTON	07/30/1991
4		250 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC:36800-604-90	500 in 1 BOTTLE; Type 0: Not a Combination Product	07/29/1993
6	NDC:36800-604-93	1000 in 1 BOTTLE; Type 0: Not a Combination Product	08/30/2007	03/31/2011
7	NDC:36800-604-76	1 in 1 CARTON	09/27/1993
7		120 in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC:36800-604-82	2 in 1 CARTON	02/15/1988
8		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA072096	02/15/1988

Labeler - Topco Associates LLC (006935977)

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Published Date (What is this?)	Version	Files
Apr 18, 2025	10 (current)	download
May 19, 2023	9	download
Dec 21, 2022	8	download
Mar 18, 2022	7	download
Dec 3, 2019	6	download
Jun 22, 2018	5	download
Oct 28, 2016	4	download
Apr 7, 2014	3	download
Nov 18, 2013	2	download
Apr 28, 2010	1	download

	RxCUI	RxNorm NAME	RxTTY
1	310965	ibuprofen 200 MG Oral Tablet	PSN
2	310965	ibuprofen 200 MG Oral Tablet	SCD
3	310965	ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet	SY

Label: TOPCARE IBUPROFEN- ibuprofen tablet, film coated

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Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

	NDC
1	36800-604-62
2	36800-604-71
3	36800-604-76
4	36800-604-78
5	36800-604-82
6	36800-604-85
7	36800-604-90
8	36800-604-93

Label: TOPCARE IBUPROFEN- ibuprofen tablet, film coated

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

TOPCARE IBUPROFEN- ibuprofen tablet, film coated

Number of versions: 10

TOPCARE IBUPROFEN- ibuprofen tablet, film coated

TOPCARE IBUPROFEN- ibuprofen tablet, film coated

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TOPCARE IBUPROFEN- ibuprofen tablet, film coated

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.