Redicare Ibuprofen 200mg

Redicare Ibuprofen 200mg
SPL v2
SPL
SPL Set ID 2f0db953-33e2-1729-e063-6294a90af074
Route
ORAL
Published
Effective Date 2025-02-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Stearic Acid Silicon Dioxide Sodium Starch Glycolate Type A Potato Ferric Oxide Red Polyethylene Glycol 4000 Starch, Corn Povidone K30 Titanium Dioxide Talc

Identifiers & Packaging

Pill Appearance
Imprint: G;2 Shape: round Color: red Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2025-02-26

Description

Ibuprofen USP, 200mg (NSAID)*

Purpose

fever reducer *nonsteroidal anti-inflammatory drug


Medication Information

Purpose

fever reducer *nonsteroidal anti-inflammatory drug

Description

Ibuprofen USP, 200mg (NSAID)*

Box

Uses:

temporarily relieves minor aches and pains due to: ■ headache ■ toothache ■ backache ■ menstrual cramps ■

the common cold ■ muscular aches ■ minor pain of arthritis ■ temporarily reduces fever

Packet

Directions:

■ do not take more than directed ■ the smallest effective dose should be used ■ adults and children 12 years and over: 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

Do Not Use:

■ if you have ever had an allergic reaction to any other pain reliever/ fever reducer ■ right before or after heart surgery

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.

Other Information:

■ store between 20-25 °C (68-77° F) ■ read all warnings and directions before use ■ do not use if packet is damaged or opened

Inactive Ingredients:

colloidal silicon dioxide, corn starch, FD&C yellow #6, hypromellose, polydextrose, polyethylene glycol, povidone, pregelatinized starch, purified water, sodium starch glycolate, stearic acid, titanium dioxide

Questions Or Comments?

Call 1-866-561-5650. Monday through Friday 9AM – 5PM EST

When Using This Product

take with food or milk if stomach upset occurs

Stomach Bleeding Warning:

This product contains a nonsteroidal anti-inflammatory drug (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

Ask A Doctor Before Use If

■ stomach bleeding warning applies to you ■ you have problems or serious side effects from taking pain relievers or fever reducers ■ 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

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 (1-800-222-1222) right away.

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.

Active Ingredient (in Each Tablet)

Ibuprofen USP, 200mg (NSAID)*

Ask A Doctor Or Pharmacist Before Use If You Are

■ under a doctor’s care for any serious condition ■ taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin ■ taking any other drug


Structured Label Content

Box

Uses:

temporarily relieves minor aches and pains due to: ■ headache ■ toothache ■ backache ■ menstrual cramps ■

the common cold ■ muscular aches ■ minor pain of arthritis ■ temporarily reduces fever

Packet

Purpose

fever reducer *nonsteroidal anti-inflammatory drug

Directions:

■ do not take more than directed ■ the smallest effective dose should be used ■ adults and children 12 years and over: 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

Do Not Use: (Do not use:)

■ if you have ever had an allergic reaction to any other pain reliever/ fever reducer ■ right before or after heart surgery

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.

Other Information:

■ store between 20-25 °C (68-77° F) ■ read all warnings and directions before use ■ do not use if packet is damaged or opened

Inactive Ingredients:

colloidal silicon dioxide, corn starch, FD&C yellow #6, hypromellose, polydextrose, polyethylene glycol, povidone, pregelatinized starch, purified water, sodium starch glycolate, stearic acid, titanium dioxide

Questions Or Comments? (Questions or Comments?)

Call 1-866-561-5650. Monday through Friday 9AM – 5PM EST

When Using This Product (When using this product)

take with food or milk if stomach upset occurs

Stomach Bleeding Warning:

This product contains a nonsteroidal anti-inflammatory drug (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

Ask A Doctor Before Use If (Ask a doctor before use if)

■ stomach bleeding warning applies to you ■ you have problems or serious side effects from taking pain relievers or fever reducers ■ 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

Stop Use and Ask A Doctor If (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, (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. (Keep out of reach of children.)

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

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.

Active Ingredient (in Each Tablet) (Active Ingredient (in each tablet))

Ibuprofen USP, 200mg (NSAID)*

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

■ under a doctor’s care for any serious condition ■ taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin ■ taking any other drug


Advanced Ingredient Data


Raw Label Data

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