Aerotab Ibuprofen Tablets

Aerotab Ibuprofen Tablets
SPL v2
SPL
SPL Set ID ddd0f7fb-ae4b-c584-e053-2a95a90a0984
Route
ORAL
Published
Effective Date 2022-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Starch, Corn Talc Croscarmellose Sodium Magnesium Stearate Polyethylene Glycol 1000 Polyvinyl Alcohol (100000 Mw) Microcrystalline Cellulose Titanium Dioxide Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Shape: round Color: brown Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2018-01-01

Description

Drug Facts Active Ingredient (in each tablet) ​Ibuprofen 200 mg (NSAID)*

Purpose

Purpose Ibuprofen 200 mg (NSAID)*.............Pain Reliever Fever Reducer *nonsteroidal anti-inflammatory drug


Medication Information

Purpose

Purpose



Ibuprofen 200 mg (NSAID)*.............Pain Reliever Fever Reducer

*nonsteroidal anti-inflammatory drug

Description

Drug Facts Active Ingredient (in each tablet) ​Ibuprofen 200 mg (NSAID)*

Warnings

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 an dseek medical help right away.

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 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, stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Active Ingredient

Drug Facts

Active Ingredient (in each tablet)

​Ibuprofen 200 mg (NSAID)*

Ibuprofen Package

AeroTab

Ibuprofen USP 200mg

Anti-inflammatory

Fever reducer

Pain reliever

250

2 per packet

Other Information

Other Information

Tamper evident. Do not use if packet is torn, cut or opened. Store between 20C to 25C (68F to 77F). Read all warnings and directions before use

Indications & Usage

Uses:

Temporarily Relieves minor aches and pains

due to:

• Headache, toothaches, backache, menstrual cramps,

the common cold,

• muscular aches, minor pain of arthritis

Temporarily reduces fever

Inactive Ingredients

Inactive Ingredients:

corn starch, hypromellose, red iron oxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch,silicon dioxide, sodium starch glycolate, talc, titanium dioxide, triacetin

Ask A Doctor Before Use

Ask a doctor before use if

  • stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or frever reducers
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, had a stroke, you are taking a diuretic

Ask a doctor or pharmacist before use if

  • you are under a doctor's care for any serious condition
  • Taking aspirin for a heart attack or stroke, because ibuprofen may decrease this benefit of asprin
  • taking any other drug

Dosage & Administration

Directions: take only as directed - see Overdose warning.

Adults and children 12 years of age 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 hoiurs, unless directed by a doctor.

Children under 12 years ask a doctor. Do not take more than directed (see overdose warning). The smallest effective dose should be used.

When Using This Product

When using this product take with food or milk if stomach upset occurs

Stop Use and Ask A Doctor

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
  • stomach pain that does not get better
  • 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 last more than 10 days
  • fever gets worse or last 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 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

Keep out of reach of children.

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

Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


Structured Label Content

Purpose (PURPOSE)

Purpose



Ibuprofen 200 mg (NSAID)*.............Pain Reliever Fever Reducer

*nonsteroidal anti-inflammatory drug

Warnings (WARNINGS)

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 an dseek medical help right away.

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 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, stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Active Ingredient (ACTIVE INGREDIENT)

Drug Facts

Active Ingredient (in each tablet)

​Ibuprofen 200 mg (NSAID)*

Ibuprofen Package

AeroTab

Ibuprofen USP 200mg

Anti-inflammatory

Fever reducer

Pain reliever

250

2 per packet

Other Information (OTHER INFORMATION)

Other Information

Tamper evident. Do not use if packet is torn, cut or opened. Store between 20C to 25C (68F to 77F). Read all warnings and directions before use

Indications & Usage (INDICATIONS & USAGE)

Uses:

Temporarily Relieves minor aches and pains

due to:

• Headache, toothaches, backache, menstrual cramps,

the common cold,

• muscular aches, minor pain of arthritis

Temporarily reduces fever

Inactive Ingredients (INACTIVE INGREDIENTS)

Inactive Ingredients:

corn starch, hypromellose, red iron oxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch,silicon dioxide, sodium starch glycolate, talc, titanium dioxide, triacetin

Ask A Doctor Before Use (ASK A DOCTOR BEFORE USE)

Ask a doctor before use if

  • stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or frever reducers
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, had a stroke, you are taking a diuretic

Ask a doctor or pharmacist before use if

  • you are under a doctor's care for any serious condition
  • Taking aspirin for a heart attack or stroke, because ibuprofen may decrease this benefit of asprin
  • taking any other drug

Dosage & Administration (DOSAGE & ADMINISTRATION)

Directions: take only as directed - see Overdose warning.

Adults and children 12 years of age 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 hoiurs, unless directed by a doctor.

Children under 12 years ask a doctor. Do not take more than directed (see overdose warning). The smallest effective dose should be used.

When Using This Product (WHEN USING THIS PRODUCT)

When using this product take with food or milk if stomach upset occurs

Stop Use and Ask A Doctor (STOP USE AND ASK A DOCTOR)

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
  • stomach pain that does not get better
  • 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 last more than 10 days
  • fever gets worse or last 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)

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 (KEEP OUT OF REACH OF CHILDREN)

Keep out of reach of children.

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

Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


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