DailyMed - IBUPROFEN tablet, film coated

Contains inactivated NDC Code(s)
NDC Code(s): 58624-7007-0, 58624-7009-0, 58624-7011-0
Packager: Shandong Xinhua Pharmaceutical Co., Ltd.

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 3, 2023

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Read all product information before using. Keep this box for important information.

Read all product information before using. Keep this box for important information.
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SPL UNCLASSIFIED SECTION
Drug Facts

Drug Facts
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Active ingredient (in each caplet)
Ibuprofen 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug
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Purpose
Pain reliever/fever reducer

Pain reliever/fever reducer
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Uses
temporarily relieves minor aches and pains due to: headache - muscular aches - minor pain of arthritis - toothache - backache - the common cold - menstrual ...
- 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
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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 ...
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 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
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.

Brown Film-Coated Caplets contain FD+C Yellow No. 5 (tartrazine) as a color additive
Do not use

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

right before or after heart surgery

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, kidney disease, asthma, or had a stroke

you are taking a diuretic

Ask a doctor or pharmacist before use if you are

taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin

under a doctor's care for any serious condition

taking any other drug

When using this product

take with food or milk if stomach upset occurs

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

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)
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Directions
do not take more than directed - the smallest effective dose should be used - adults and children 12 years and older - take 1 caplet every 4 to 6 hours while symptoms persist - if pain or fever ...
- do not take more than directed
- the smallest effective dose should be used
adults and children 12 years and older
- take 1 caplet every 4 to 6 hours while symptoms persist
- if pain or fever does not respond to 1 caplet, 2 caplets may be used
- do not exceed 6 caplets in 24 hours, unless directed by a doctor
children under 12 years
- ask a doctor
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Other information
store between 20-25°C (68-77°F) do not use if the inner seal imprinted with "SEALED for YOUR PROTECTION" is broken or missing
- store between 20-25°C (68-77°F)
- do not use if the inner seal imprinted with "SEALED for YOUR PROTECTION" is broken or missing
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INACTIVE INGREDIENT

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Questions or comments?
Call - 1-844-374-0016 Monday through Friday 9AM - 5PM EST.

Call 1-844-374-0016 Monday through Friday 9AM - 5PM EST.
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PRINCIPAL DISPLAY PANEL
Ibuprofen tablets are available in the following colors and sizes: Orange, Capsule-shaped Tablet, debossed with BI 03 - Bottles of 24 NDC 58624-7007-0 - White, Capsule-shaped Tablet, debossed ...

Ibuprofen tablets are available in the following colors and sizes:

Orange, Capsule-shaped Tablet, debossed with BI 03

Bottles of 24 NDC 58624-7007-0

White, Capsule-shaped Tablet, debossed with BI 05

Bottles of 24 NDC 58624-7009-0

Brown, Capsule-shaped Tablet, debossed with BI 07

Bottles of 24 NDC 58624-7011-0

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INGREDIENTS AND APPEARANCE

Product Information

IBUPROFEN ibuprofen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58624-7007
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)
POLYVINYL ALCOHOL (UNII: 532B59J990)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange	Score	no score
Shape	CAPSULE	Size	15mm
Flavor		Imprint Code	BI;03
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58624-7007-0	1 in 1 CARTON	04/05/2022
1		24 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA207095	04/05/2022

IBUPROFEN ibuprofen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58624-7009
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)
POLYVINYL ALCOHOL (UNII: 532B59J990)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	15mm
Flavor		Imprint Code	BI;05
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58624-7009-0	1 in 1 CARTON	04/05/2022
1		24 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA207095	04/05/2022

IBUPROFEN ibuprofen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58624-7011
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FERRIC OXIDE RED (UNII: 1K09F3G675)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)
POLYVINYL ALCOHOL (UNII: 532B59J990)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	brown	Score	no score
Shape	CAPSULE	Size	15mm
Flavor		Imprint Code	BI;07
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58624-7011-0	1 in 1 CARTON	04/05/2022
1		24 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA207095	04/05/2022

Labeler - Shandong Xinhua Pharmaceutical Co., Ltd. (653915728)

Registrant - Shandong Xinhua Pharmaceutical Co., Ltd. (554507599)

Name	Address	ID/FEI	Business Operations
Establishment
Shandong Xinhua Pharmaceutical Co., Ltd.		554507599	manufacture(58624-7007, 58624-7009, 58624-7011)

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Published Date (What is this?)	Version	Files
Mar 6, 2023	2 (current)	download
Dec 29, 2022	1	download

	RxCUI	RxNorm NAME	RxTTY
1	310965	ibuprofen 200 MG Oral Tablet	PSN
2	310965	ibuprofen 200 MG Oral Tablet	SCD
3	310965	ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet	SY

	NDC
1	58624-7007-0 (inactivated)
2	58624-7009-0 (inactivated)
3	58624-7011-0 (inactivated)

Label: IBUPROFEN tablet, film coated

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Label: IBUPROFEN tablet, film coated

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IBUPROFEN tablet, film coated

Number of versions: 2

IBUPROFEN tablet, film coated

IBUPROFEN tablet, film coated

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IBUPROFEN tablet, film coated

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.