Ibuprofen

Ibuprofen
SPL v2
SPL
SPL Set ID 218f6df9-dd04-45b6-8a45-3276691abee2
Route
ORAL
Published
Effective Date 2024-04-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Croscarmellose Sodium Fd&c Blue No. 2 Fd&c Red No. 40 Fd&c Yellow No. 6 Hypromellose, Unspecified Ferric Oxide Red Lactose Monohydrate Magnesium Stearate Maltodextrin Medium-chain Triglycerides Microcrystalline Cellulose Polydextrose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Povidone K30 Silicon Dioxide Sodium Starch Glycolate Type A Starch, Corn Stearic Acid Talc Titanium Dioxide Triacetin

Identifiers & Packaging

Pill Appearance
Imprint: G2 Shape: round Color: brown Size: 10 mm Score: 2
Marketing Status
ANDA Active Since 2000-02-02

Description

Drug Facts

Purpose

pain reliever/fever reducer


Medication Information

Purpose

pain reliever/fever reducer

Description

Drug Facts

Use

temporarily relieves fever and minor aches and pains associated with:

  • common cold
  • backache
  • headache
  • toothache
  • arthritis
  • muscular aches
  • menstrual cramps
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

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
  • 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
Section 53414-9

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.

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: 1 tablet every 4 to 6 hours while symptoms occur; if pain or fever does not respond to 1 tablet, 2 tablets may be used, but 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 ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
Questions?

1-866-651-3660 Monday-Friday

8:00am-5:00pm EST

Allergy Alert

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • hives
  • asthma (wheezing)
  • facial swelling
  • shock
  • skin reddening
  • rash
  • blisters
  • If an allergic reaction occurs, stop use and seek medical help right away.
Other Information
  • do not use if packet is opened or torn
  • Store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)
Inactive Ingredients

crosscarmellose sodium

contains one or more of these ingredients
, FD& C Blue #2
, FD& C red #40
, FD& C Yellow #6
, hypromellose
, iron oxide red
, lactose monohydrate
, magnesium stearate
, maltodextrin
, medium chain triglycerides
, microcrystalline cellulose
, polydextrose
, polyethylene glycol
, polyvinyl alcohol
, povidone (K-30)
, silicon dioxide, sodium starch glycolate
, starch, stearic acid
, talc
, titanium dioxide, triacetin
,

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
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 a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
Active Ingredient (in Each Tablets)

Ibuprofen, USP 200 mg (NSAID)

*Nonsteroidal Anti-Inflammatory Drug

Principal Display Panel 100 Tablet Packet Box

This product is not manufactured or distributed by

Pfizer Consumer Healthcare

Owner of the registered trademark Advil®.

Product #1102

Ibuprofen

Pain Reliever/Fever Reducer

Active ingredient:

Ibuprofen

  • Temporary relief from pain, fever and inflammation
  • Soothes muscles aches and minor arthritis pain
  • Non-drowsy, aspirin-free formula

These quality comfort tablets are formulated and packaged for use in the

workplace and meet ANSI Z308.1-2015 standards. They are sealed in

tamper-evident packets for safety and convenience.

100 Tablets • 2 Tablets Per Packet

Principal Display Panel 250 Tablet Packet Box

Product #1104

Ibuprofen

Pain Reliever/Fever Reducer

Active ingredient:

Ibuprofen

  • Temporary relief from pain, fever and inflammation
  • Soothes muscles aches and minor arthritis pain
  • Non-drowsy, aspirin-free formula

These quality comfort tablets are formulated and packaged for use in the

workplace and meet ANSI Z308.1-2015 standards. They are sealed in

tamper-evident packets for safety and convenience.

250 Tablets • 2 Tablets Per Packet

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) drug
  • under a doctor's care for any serious condition
  • taking any other drug

Structured Label Content

Use

temporarily relieves fever and minor aches and pains associated with:

  • common cold
  • backache
  • headache
  • toothache
  • arthritis
  • muscular aches
  • menstrual cramps
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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
  • 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
Section 53414-9 (53414-9)

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.

Purpose

pain reliever/fever reducer

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: 1 tablet every 4 to 6 hours while symptoms occur; if pain or fever does not respond to 1 tablet, 2 tablets may be used, but 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 ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
Questions?

1-866-651-3660 Monday-Friday

8:00am-5:00pm EST

Allergy Alert

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • hives
  • asthma (wheezing)
  • facial swelling
  • shock
  • skin reddening
  • rash
  • blisters
  • If an allergic reaction occurs, stop use and seek medical help right away.
Other Information
  • do not use if packet is opened or torn
  • Store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)
Inactive Ingredients

crosscarmellose sodium

contains one or more of these ingredients
, FD& C Blue #2
, FD& C red #40
, FD& C Yellow #6
, hypromellose
, iron oxide red
, lactose monohydrate
, magnesium stearate
, maltodextrin
, medium chain triglycerides
, microcrystalline cellulose
, polydextrose
, polyethylene glycol
, polyvinyl alcohol
, povidone (K-30)
, silicon dioxide, sodium starch glycolate
, starch, stearic acid
, talc
, titanium dioxide, triacetin
,

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
Stomach Bleeding Warning (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 a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
Active Ingredient (in Each Tablets) (Active ingredient (In Each Tablets))

Ibuprofen, USP 200 mg (NSAID)

*Nonsteroidal Anti-Inflammatory Drug

Principal Display Panel 100 Tablet Packet Box (PRINCIPAL DISPLAY PANEL - 100 Tablet Packet Box)

This product is not manufactured or distributed by

Pfizer Consumer Healthcare

Owner of the registered trademark Advil®.

Product #1102

Ibuprofen

Pain Reliever/Fever Reducer

Active ingredient:

Ibuprofen

  • Temporary relief from pain, fever and inflammation
  • Soothes muscles aches and minor arthritis pain
  • Non-drowsy, aspirin-free formula

These quality comfort tablets are formulated and packaged for use in the

workplace and meet ANSI Z308.1-2015 standards. They are sealed in

tamper-evident packets for safety and convenience.

100 Tablets • 2 Tablets Per Packet

Principal Display Panel 250 Tablet Packet Box (PRINCIPAL DISPLAY PANEL - 250 Tablet Packet Box)

Product #1104

Ibuprofen

Pain Reliever/Fever Reducer

Active ingredient:

Ibuprofen

  • Temporary relief from pain, fever and inflammation
  • Soothes muscles aches and minor arthritis pain
  • Non-drowsy, aspirin-free formula

These quality comfort tablets are formulated and packaged for use in the

workplace and meet ANSI Z308.1-2015 standards. They are sealed in

tamper-evident packets for safety and convenience.

250 Tablets • 2 Tablets Per Packet

Ask A Doctor Or Pharmacist Before Use If You Are (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) drug
  • under a doctor's care for any serious condition
  • taking any other drug

Advanced Ingredient Data


Raw Label Data

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