Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID ab07e341-51a3-4d8d-b584-0719da994c1c
Route
ORAL
Published
Effective Date 2015-04-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Silicon Dioxide Starch, Corn Hypromelloses Ferric Oxide Red Magnesium Stearate Cellulose, Microcrystalline Sodium Starch Glycolate Type A Corn Titanium Dioxide Lactose Polydextrose Polyethylene Glycols

Identifiers & Packaging

Pill Appearance
Imprint: 44291 Shape: round Color: brown Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2015-04-17

Description

Ibuprofen USP, 200mg (NSAID)** **nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Ibuprofen USP, 200mg (NSAID)** **nonsteroidal anti-inflammatory drug

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 a nonsteroidal anti-inflammatory drug (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.

Directions

do not take more than directed

■ the smallest effective dose should be used

do not take longer than 10 days, unless directed by a doctor (see Warnings)

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

Do Not Use

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

after heart surgery

Active Ingredient

Ibuprofen USP, 200mg (NSAID)**

**nonsteroidal anti-inflammatory drug

Other Information

store between 20-25 °C (68-77° F).■ Read all warnings and directions before useDo not use if

seal under bottle cap is broken or missing.

Inactive Ingredients

colloidal silicon dioxide, corn starch, hypromellose, iron oxide red, magnesium stearate,

microcrystalline cellulose, sodium starch glycolate, titanium dioxide, carnuba wax, lactose, polydextrose, polyethylene glycol

Questions Or Comments?

Call 1-888-952-0050 Monday through Friday 9AM – 5PM EST.

When Using This Product

take with food or milk if stomach upset occurs

long term continuous use may increase the risk of heart attack or stroke

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, or kidney disease ■ you have asthma ■ you are taking a diuretic

Stop Use and Ask A Doctor If

you faint, vomit blood, have bloody or black stools. These are signs of stomach bleeding. pain gets worse or lasts more than 10 days ■ fever gets worse or lasts more than 3 days stomach pain or upset gets worse or lasts 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 during the last 3 months of 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).

Package/label Principal Display Panel

Dragon Tabs

Ibuprofen 200 mg/Ibuprofeno 200mg

Pain Reliever/Fever Reducer (NSAID)

Alivia el Dolor/Reduce la fiebre (AINE)

Temporarily Relieves:

Backache

Muscular aches



Alivio Temporal de:

Dolor de Espalda

Dolores Musculares

40 Tablets/Tabletas

Ask A Doctor Or Pharmacist Before Use If

you are taking any other drug containing an NSAID (prescription or nonprescription) taking a

blood thinning (anticoagulant) or steroid drug under a doctor’s care for any serious condition

taking any other drug


Structured Label Content

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

Purpose

Pain reliever/fever reducer

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 a nonsteroidal anti-inflammatory drug (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.

Directions

do not take more than directed

■ the smallest effective dose should be used

do not take longer than 10 days, unless directed by a doctor (see Warnings)

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

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

Active Ingredient (Active ingredient)

Ibuprofen USP, 200mg (NSAID)**

**nonsteroidal anti-inflammatory drug

Other Information (Other information)

store between 20-25 °C (68-77° F).■ Read all warnings and directions before useDo not use if

seal under bottle cap is broken or missing.

Inactive Ingredients

colloidal silicon dioxide, corn starch, hypromellose, iron oxide red, magnesium stearate,

microcrystalline cellulose, sodium starch glycolate, titanium dioxide, carnuba wax, lactose, polydextrose, polyethylene glycol

Questions Or Comments? (Questions or Comments?)

Call 1-888-952-0050 Monday through Friday 9AM – 5PM EST.

When Using This Product (When using this product)

take with food or milk if stomach upset occurs

long term continuous use may increase the risk of heart attack or stroke

Ask A Doctor Before Use If (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, or kidney disease ■ you have asthma ■ you are taking a diuretic

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

you faint, vomit blood, have bloody or black stools. These are signs of stomach bleeding. pain gets worse or lasts more than 10 days ■ fever gets worse or lasts more than 3 days stomach pain or upset gets worse or lasts 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 during the last 3 months of 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).

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Dragon Tabs

Ibuprofen 200 mg/Ibuprofeno 200mg

Pain Reliever/Fever Reducer (NSAID)

Alivia el Dolor/Reduce la fiebre (AINE)

Temporarily Relieves:

Backache

Muscular aches



Alivio Temporal de:

Dolor de Espalda

Dolores Musculares

40 Tablets/Tabletas

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

you are taking any other drug containing an NSAID (prescription or nonprescription) taking a

blood thinning (anticoagulant) or steroid drug under a doctor’s care for any serious condition

taking any other drug


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)