Ibuprofen, Lil' Drug Store ®

Ibuprofen, Lil' Drug Store ®
SPL v1
SPL
SPL Set ID 18e80dab-6837-fd2d-e063-6294a90a73c8
Route
ORAL
Published
Effective Date 2011-01-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Starch, Corn Magnesium Stearate Sodium Starch Glycolate Type A Potato Silicon Dioxide Stearic Acid Titanium Dioxide Polydextrose Ferric Oxide Red Anhydrous Lactose Hypromellose, Unspecified Carnauba Wax Microcrystalline Cellulose Polyethylene Glycol, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: 44;291 Shape: round Color: brown Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-02-05

Description

Drug Facts

Purpose

Pain reliever/Fever reducer


Medication Information

Purpose

Pain reliever/Fever reducer

Description

Drug Facts

Uses

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
Warnings

Warnings

Directions

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 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
Drug Facts

Drug Facts

Allergy Alert

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.

Active Ingredient

Active ingredient (in each tablet)

Ibuprofen Tablet USP, 200 mg ( NSAID*)

*nonsteroidal anti-inflammatory drug

Other Information

​Other information

  • store between 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).
Inactive Ingredients

​Inactive ingredients

carnauba wax, colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide

Questions Or Comments?

​Questions or comments?​

call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

When Using This Produc

When using this product

  • take with food or milk if stomach upset occurs
Ask A Doctor Before Use

Ask a doctor before use if

  • the 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
Stomach Bleeding Warning

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
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
  • 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
Ask A Doctor Or Pharmacist

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
Ibuprofen, Lil' Drug Store ®

QUALITY GUARANTEED

Compare to the Active

Ingredient in Advil® Tablets**

Ibuprofen

Tablets USP, 200 mg (NSAID)

Pain Reliever/Fever Reducer



12

Tablets

[Lil' Drug Store® logo]

OPEN HERE FOR DRUG FACTS INFORMATION

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

Heart Attack and Stroke Warning

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.


Structured Label Content

Uses

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
Purpose

Pain reliever/Fever reducer

Warnings

Warnings

Directions

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 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)

Do not use

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
Drug Facts (Drug facts)

Drug Facts

Allergy Alert (Allergy alert)

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.

Active Ingredient (Active ingredient)

Active ingredient (in each tablet)

Ibuprofen Tablet USP, 200 mg ( NSAID*)

*nonsteroidal anti-inflammatory drug

Other Information (Other information)

​Other information

  • store between 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).
Inactive Ingredients (Inactive ingredients)

​Inactive ingredients

carnauba wax, colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide

Questions Or Comments? (Questions or comments?)

​Questions or comments?​

call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

When Using This Produc (When using this produc)

When using this product

  • take with food or milk if stomach upset occurs
Ask A Doctor Before Use (Ask a doctor before use)

Ask a doctor before use if

  • the 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
Stomach Bleeding Warning (Stomach bleeding warning)

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
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
  • 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
Ask A Doctor Or Pharmacist (Ask a doctor or pharmacist)

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
Ibuprofen, Lil' Drug Store ®

QUALITY GUARANTEED

Compare to the Active

Ingredient in Advil® Tablets**

Ibuprofen

Tablets USP, 200 mg (NSAID)

Pain Reliever/Fever Reducer



12

Tablets

[Lil' Drug Store® logo]

OPEN HERE FOR DRUG FACTS INFORMATION

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 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)

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).

Heart Attack and Stroke Warning (Heart attack and stroke warning)

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.


Advanced Ingredient Data


Raw Label Data

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