OTC Medication Information: Topcare Ibuprofen

TOPCARE IBUPROFEN- ibuprofen tablet, film coated
Topco Associates LLC

Active ingredient (in each caplet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Uses

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

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 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 chances are 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).

Directions

do not take more than directed
the smallest effective dose should be used

adults and children 12 years and older

take 1 caplet every 4 to 6 hours while symptoms persist
if pain or fever does not respond to 1 caplet, 2 caplets may be used
do not exceed 6 caplets in 24 hours, unless directed by a doctor

children under 12 years

ask a doctor

Other information

read all warnings and directions before use
store between 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

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, iron oxides, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, stearic acid, talc, titanium dioxide

Questions or comments?

1-888-423-0139

Principal Display Panel

TopCare® health

C OMPARE TO MOTRIN® IB ACTIVE INGREDIENT

SEE REVISED WARNING

Ibuprofen Tablets, 200 mg

PAIN RELIEVER • FEVER REDUCER (NSAID)

100 CAPLETS†

†CAPSULE-SHAPED TABLETS

I-2®

actual size

Ibuprofen Tablets Carton
(click image for full-size original)
TOPCARE IBUPROFEN
ibuprofen tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-517
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
CROSCARMELLOSE SODIUM
FD&C RED NO. 40
FD&C YELLOW NO. 6
FERRIC OXIDE RED
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
STEARIC ACID
TALC
TITANIUM DIOXIDE
Product Characteristics
Color ORANGE Score no score
Shape OVAL Size 15mm
Flavor Imprint Code I2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36800-517-71 1 BOTTLE in 1 CARTON contains a BOTTLE
1 50 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (36800-517-71)
2 NDC:36800-517-78 1 BOTTLE in 1 CARTON contains a BOTTLE
2 100 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (36800-517-78)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077349 04/28/2006
Labeler — Topco Associates LLC (006935977)

Revised: 08/2023 Topco Associates LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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