DailyMed - IBUPROFEN SOFTGELS- ibuprofen capsule

Contains inactivated NDC Code(s)
NDC Code(s): 70729-000-01, 70729-000-02, 70729-509-32
Packager: Breeden Brothers, LLC

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

Drug Label Information

Updated January 1, 2018

If you are a consumer or patient please visit this version.

Download DRUG LABEL INFO: PDF XML
Official Label (Printer Friendly)

View All Sections

SPL UNCLASSIFIED SECTION
Drug Facts

Drug Facts
Close
Active ingredient (in each capsule)
Solubilized ibuprofen equal to Pain reliever/ 200 mg ibuprofen (NSAID)* *nonsteroidal anti-inflammatory drug

Solubilized ibuprofen equal to Pain reliever/ 200 mg ibuprofen (NSAID)*

*nonsteroidal anti-inflammatory drug
Close
Purpose
fever reducer (present as the free acid and potassium salt) Drug Facts (continued)

fever reducer (present as the free acid and potassium salt)

Drug Facts (continued)
Close
Uses
_ temporarily relieves minor aches and pains due to: _ muscular aches - _ the common cold - _ headache - _ toothache - _ backache - _ menstrual cramps - _ minor pain of arthritis - _ temporarily reduces ...

_ temporarily relieves minor aches and pains due to:

_ muscular aches

_ the common cold

_ headache

_ toothache

_ backache

_ menstrual cramps

_ minor pain of arthritis

_ temporarily reduces fever
Close
Warnings
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: _ blisters - _ rash - _ hives - _ asthma (wheezing) _ shock - _ skin ...

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

_ blisters

_ rash

_ hives

_ asthma (wheezing)

_ shock

_ skin reddening

_ facial swelling

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 a blood thinning (anticoagulant) or

Drug Facts (continued)

steroid drug

_ are age 60 or older

_ have had stomach ulcers or bleeding problems

_ 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

Do not use

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

_ right before or after heart surgery

Ask a doctor before use if

_ stomach bleeding warning applies to you

_ you have a history of stomach problems, such as heartburn

_ you are taking a diuretic

Drug Facts (continued)

_ you have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma

_ you have problems or serious side effects from taking pain relievers or fever reducers

Ask a doctor or pharmacist before use if you are

_ taking any other drug

_ under a doctor's care for any serious condition

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

When using this product

_ take with food or milk if stomach upset occurs

_ the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if

_ you experience any of the following signs of

Drug Facts (continued)

stomach bleeding:

_ feel faint

_ have stomach pain that does not get better

_ have bloody or black stools

_ vomit blood

_ 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)

Drug Facts (continued)

Close
Directions
_ do not take more than directed - _ the smallest effective dose should be used - _ adults and children 12 years and over: take 1 capsule 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 over: take 1 capsule every 4 to 6 hours while symptoms persist

_ if pain or fever does not respond to 1 capsule, 2 capsules may be used

_ do not exceed 6 capsules in 24 hours, unless directed by a doctor

_ children under 12 years: ask a doctor
Close
Other information
_ each capsule contains: potassium 28 mg - _ read all warnings and directions before use. _ store at 20°-25°C (68°-77°F) _ avoid excessive heat above 40°C (104°F) Drug Facts (continued)

_ each capsule contains: potassium 28 mg

_ read all warnings and directions before use.

_ store at 20°-25°C (68°-77°F)

_ avoid excessive heat above 40°C (104°F)

Drug Facts (continued)
Close
Inactive ingredients
FD&C green #3, gelatin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, potassium hydroxide, purified water, sorbitol special, and white edible ink

FD&C green #3, gelatin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, potassium hydroxide, purified water, sorbitol special, and white edible ink
Close
Questions or comments?
1-800-901-2420 - Product of China

1-800-901-2420

Product of China
Close
PRINCIPAL DISPLAY PANEL
b+b - better by giving - IBUPROFEN - SOFTGELS - 20 Softgels - (200 mg each)

b+b
better by giving
IBUPROFEN
SOFTGELS
20 Softgels
(200 mg each)

Close
PRINCIPAL DISPLAY PANEL
b+b - better by giving - IBUPROFEN - SOFTGELS - 40 Softgels - (200 mg each)

b+b
better by giving
IBUPROFEN
SOFTGELS
40 Softgels
(200 mg each)

Close
PRINCIPAL DISPLAY PANEL
NDC 70729-509-32 - b+b - IBUPROFEN - SOFTGELS - 120 Softgels - (200 mg each)

NDC 70729-509-32
b+b
IBUPROFEN
SOFTGELS
120 Softgels
(200 mg each)

Close

INGREDIENTS AND APPEARANCE

Product Information

IBUPROFEN SOFTGELS ibuprofen capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70729-000
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
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
GELATIN (UNII: 2G86QN327L)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	GREEN	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70729-000-01	20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/2018
2	NDC:70729-000-02	40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA206568	02/01/2018

IBUPROFEN SOFTGELS ibuprofen capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70729-509
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
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
GELATIN (UNII: 2G86QN327L)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	GREEN	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70729-509-32	120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA206568	02/01/2018

Labeler - Breeden Brothers, LLC (080131046)

View All Sections

Published Date (What is this?)	Version	Files
Oct 1, 2018	2 (current)	download
Feb 1, 2018	1	download

	RxCUI	RxNorm NAME	RxTTY
1	310964	ibuprofen 200 MG Oral Capsule	PSN
2	310964	ibuprofen 200 MG Oral Capsule	SCD

	NDC
1	70729-000-01 (inactivated)
2	70729-000-02 (inactivated)
3	70729-509-32 (inactivated)

Label: IBUPROFEN SOFTGELS- ibuprofen capsule

View Package Photos

VIEW MORE

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

Label: IBUPROFEN SOFTGELS- ibuprofen capsule

View Package Photos

VIEW MORE

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

IBUPROFEN SOFTGELS- ibuprofen capsule

Number of versions: 2

IBUPROFEN SOFTGELS- ibuprofen capsule

IBUPROFEN SOFTGELS- ibuprofen capsule

To receive this label RSS feed

To receive all DailyMed Updates for the last seven days

What will I get with the DailyMed RSS feed?

How to discontinue the RSS feed

Why is DailyMed no longer displaying pill images on the Search Results and Drug Info pages?

IBUPROFEN SOFTGELS- ibuprofen capsule

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