44-438-dsp - DailyMed Details

44-438-dsp

SPL v16

SPL

SPL Set ID 260f5862-d65d-4c34-bf53-26ca30806a67

Route

ORAL

Published

Effective Date 2026-01-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Ibuprofen (200 mg)

Inactive Ingredients

Silicon Dioxide Starch, Corn Hypromellose, Unspecified Anhydrous Lactose Magnesium Stearate Microcrystalline Cellulose Polydextrose Polyethylene Glycol, Unspecified Povidone, Unspecified Sodium Starch Glycolate Type A Potato Stearic Acid Triacetin

Identifiers & Packaging

Pill Appearance

Imprint: 44;438 Shape: round Color: white Size: 10 mm Score: 1

Marketing Status

ANDA Active Since 2011-06-03

Description

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

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

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

Overbagged with 10 film-coated tablets per bag, NDC 55154-0669-0

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Distributed By:

Cardinal Health

Dublin, OH 43017

L3432333-11024 / L3432333-21024

Rev. 12/25

M-17

Re-order No. 301559

Uses

▪
temporarily relieves minor aches and pains due to:
- ▪
  backache
- ▪
  menstrual cramps
- ▪
  toothache
- ▪
  muscular aches
- ▪
  headache
- ▪
  the common cold
- ▪
  minor pain of arthritis
▪
temporarily reduces fever

Warnings

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

▪
rash
▪
facial swelling
▪
shock
▪
blisters
▪
skin reddening
▪
hives
▪
asthma (wheezing)

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

▪
take more or for a longer time than directed
▪
take a blood thinning (anticoagulant) or steroid drug
▪
are age 60 or older
▪
have 3 or more alcoholic drinks every day while using this product
▪
take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
▪
have had stomach ulcers or bleeding problems

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.

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

Other Information

▪
store between 20°-25°C (68°-77°F)
▪
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
▪
avoid excessive heat 40°C (104°F)
▪
use by expiration date on package

Inactive Ingredients

colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, triacetin

Questions Or Comments?

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal Display Panel

NDC 55154-0669-0

IBUPROFEN TABLETS, USP 200mg

Pain Reliever/Fever Reducer (NSAID)

10 TABLETS

When Using This Product

▪
take with food or milk if stomach upset occurs

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, kidney disease, asthma, or had a stroke
▪
you are taking a diuretic
▪
you have problems or serious side effects from taking pain relievers or fever reducers

Stop Use and Ask A Doctor If

▪
you experience any of the following signs of stomach bleeding:
- ▪
  feel faint
- ▪
  have bloody or black stools
- ▪
  vomit blood
- ▪
  have stomach pain that does not get better
▪
you have symptoms of heart problems or stroke:
- ▪
  chest pain
- ▪
  slurred speech
- ▪
  leg swelling
- ▪
  trouble breathing
- ▪
  weakness in one part or side of body
▪
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 right away.

Active Ingredient (in Each White Tablet)

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

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

Overbagged with 10 film-coated tablets per bag, NDC 55154-0669-0

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Distributed By:

Cardinal Health

Dublin, OH 43017

L3432333-11024 / L3432333-21024

Rev. 12/25

M-17

Re-order No. 301559

Uses

▪
temporarily relieves minor aches and pains due to:
- ▪
  backache
- ▪
  menstrual cramps
- ▪
  toothache
- ▪
  muscular aches
- ▪
  headache
- ▪
  the common cold
- ▪
  minor pain of arthritis
▪
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:

▪
rash
▪
facial swelling
▪
shock
▪
blisters
▪
skin reddening
▪
hives
▪
asthma (wheezing)

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

▪
take more or for a longer time than directed
▪
take a blood thinning (anticoagulant) or steroid drug
▪
are age 60 or older
▪
have 3 or more alcoholic drinks every day while using this product
▪
take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
▪
have had stomach ulcers or bleeding problems

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

Other Information (Other information)

▪
store between 20°-25°C (68°-77°F)
▪
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
▪
avoid excessive heat 40°C (104°F)
▪
use by expiration date on package

Inactive Ingredients (Inactive ingredients)

Questions Or Comments? (Questions or comments?)

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal Display Panel

NDC 55154-0669-0

IBUPROFEN TABLETS, USP 200mg

Pain Reliever/Fever Reducer (NSAID)

10 TABLETS

When Using This Product (When using this product)

▪
take with food or milk if stomach upset occurs

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, kidney disease, asthma, or had a stroke
▪
you are taking a diuretic
▪
you have problems or serious side effects from taking pain relievers or fever reducers

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
- ▪
  have bloody or black stools
- ▪
  vomit blood
- ▪
  have stomach pain that does not get better
▪
you have symptoms of heart problems or stroke:
- ▪
  chest pain
- ▪
  slurred speech
- ▪
  leg swelling
- ▪
  trouble breathing
- ▪
  weakness in one part or side of body
▪
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,)

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.

Active Ingredient (in Each White Tablet) (Active ingredient (in each white tablet))

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

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

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Raw Label Data

All Sections (JSON)

{".": "Overbagged with 10 film-coated tablets per bag, NDC 55154-0669-0 WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children. Distributed By: Cardinal Health Dublin, OH 43017 L3432333-11024 / L3432333-21024 Rev. 12/25 M-17 Re-order No. 301559", "Uses": "▪ temporarily relieves minor aches and pains due to: ▪ backache ▪ menstrual cramps ▪ toothache ▪ muscular aches ▪ headache ▪ the common cold ▪ minor pain of arthritis ▪ 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: ▪ rash ▪ facial swelling ▪ shock ▪ blisters ▪ skin reddening ▪ hives ▪ asthma (wheezing) If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you ▪ take more or for a longer time than directed ▪ take a blood thinning (anticoagulant) or steroid drug ▪ are age 60 or older ▪ have 3 or more alcoholic drinks every day while using this product ▪ take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] ▪ have had stomach ulcers or bleeding problems 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.", "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", "Other information": "▪ store between 20°-25°C (68°-77°F) ▪ TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN ▪ avoid excessive heat 40°C (104°F) ▪ use by expiration date on package", "Inactive ingredients": "colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, triacetin", "Questions or comments?": "Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday", "Principal Display Panel": "NDC 55154-0669-0 IBUPROFEN TABLETS, USP 200mg Pain Reliever/Fever Reducer (NSAID) 10 TABLETS", "When using this product": "▪ take with food or milk if stomach upset occurs", "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, kidney disease, asthma, or had a stroke ▪ you are taking a diuretic ▪ you have problems or serious side effects from taking pain relievers or fever reducers", "Stop use and ask a doctor if": "▪ you experience any of the following signs of stomach bleeding: ▪ feel faint ▪ have bloody or black stools ▪ vomit blood ▪ have stomach pain that does not get better ▪ you have symptoms of heart problems or stroke: ▪ chest pain ▪ slurred speech ▪ leg swelling ▪ trouble breathing ▪ weakness in one part or side of body ▪ 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 right away.", "Active ingredient (in each white tablet)": "Ibuprofen USP, 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug", "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:59.268199 · Updated: 2026-03-14T23:12:35.594126