DailyMed - IBUPROFEN tablet, film coated

NDC Code(s): 71335-2068-0, 71335-2068-1, 71335-2068-2, 71335-2068-3, view more
71335-2068-4, 71335-2068-5, 71335-2068-6, 71335-2068-7, 71335-2068-8, 71335-2068-9
Packager: Bryant Ranch Prepack
This is a repackaged label.
Source NDC Code(s): 0904-7912

Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 25, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

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Official Label (Printer Friendly)

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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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Purposes
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 cramps - • temporarily reduces ...

•

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 chances are 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]

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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.

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 ...

•

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
• read all warnings and directions before use • store at 20-25°C (68-77°F) • avoid high humidity and excessive heat above 40°C (104°F)

•

read all warnings and directions before use

•

store at 20-25°C (68-77°F)

•

avoid high humidity and excessive heat above 40°C (104°F)

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Inactive ingredients
colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, polysorbate 80, stearic acid ...

colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, polysorbate 80, stearic acid, titanium dioxide
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Questions or comments?
1-800-616-2471

1-800-616-2471
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HOW SUPPLIED
NDC: 71335-2068-1: 20 Tablets in a BOTTLE - NDC: 71335-2068-2: 15 Tablets in a BOTTLE - NDC: 71335-2068-3: 30 Tablets in a BOTTLE - NDC: 71335-2068-4: 100 Tablets in a BOTTLE - NDC: 71335-2068-5: 60 ...

NDC: 71335-2068-1: 20 Tablets in a BOTTLE

NDC: 71335-2068-2: 15 Tablets in a BOTTLE

NDC: 71335-2068-3: 30 Tablets in a BOTTLE

NDC: 71335-2068-4: 100 Tablets in a BOTTLE

NDC: 71335-2068-5: 60 Tablets in a BOTTLE

NDC: 71335-2068-6: 50 Tablets in a BOTTLE

NDC: 71335-2068-7: 40 Tablets in a BOTTLE

NDC: 71335-2068-8: 10 Tablets in a BOTTLE

NDC: 71335-2068-9: 56 Tablets in a BOTTLE

NDC: 71335-2068-0: 90 Tablets in a BOTTLE

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504
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PRINCIPAL DISPLAY PANEL (What is this?)
Ibuprofen 200mg Tablet

Ibuprofen 200mg Tablet

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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:71335-2068(NDC:0904-7912)
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)
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BROWN	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code	I2
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71335-2068-1	20 in 1 BOTTLE; Type 0: Not a Combination Product	03/29/2022
2	NDC:71335-2068-2	15 in 1 BOTTLE; Type 0: Not a Combination Product	03/29/2022
3	NDC:71335-2068-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	03/29/2022
4	NDC:71335-2068-4	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/29/2022
5	NDC:71335-2068-5	60 in 1 BOTTLE; Type 0: Not a Combination Product	03/29/2022
6	NDC:71335-2068-6	50 in 1 BOTTLE; Type 0: Not a Combination Product	03/29/2022
7	NDC:71335-2068-7	40 in 1 BOTTLE; Type 0: Not a Combination Product	03/29/2022
8	NDC:71335-2068-8	10 in 1 BOTTLE; Type 0: Not a Combination Product	03/29/2022
9	NDC:71335-2068-9	56 in 1 BOTTLE; Type 0: Not a Combination Product	03/29/2022
10	NDC:71335-2068-0	90 in 1 BOTTLE; Type 0: Not a Combination Product	03/29/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA072096	08/16/1994

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(71335-2068) , RELABEL(71335-2068)

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Published Date (What is this?)	Version	Files
Oct 26, 2023	101 (current)	download
May 3, 2022	100	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

Label: IBUPROFEN tablet, film coated

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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

	NDC
1	71335-2068-0
2	71335-2068-1
3	71335-2068-2
4	71335-2068-3
5	71335-2068-4
6	71335-2068-5
7	71335-2068-6
8	71335-2068-7
9	71335-2068-8
10	71335-2068-9

Label: IBUPROFEN tablet, film coated

View Package Photos

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 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.