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NDC 10267-3846-02 ibuprofen 200 mg/1 Details

ibuprofen 200 mg/1

ibuprofen is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Contract Pharmacal Corp.. The primary component is IBUPROFEN.

MedlinePlus Drug Summary

Prescription ibuprofen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). It is also used to relieve mild to moderate pain, including menstrual pain (pain that happens before or during a menstrual period). Nonprescription ibuprofen is used to reduce fever and to relieve minor aches and pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches. Ibuprofen is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.

Related Packages: 10267-3846-02
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ibuprofen

Product Information

NDC	10267-3846
Product ID	10267-3846_77cf0092-7436-14ba-e053-2991aa0ac112
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	ibuprofen
Proprietary Name Suffix	n/a
Non-Proprietary Name	ibuprofen
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	200
Active Ingredient Units	mg/1
Substance Name	IBUPROFEN
Labeler Name	Contract Pharmacal Corp.
Pharmaceutical Class	Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA071265
Listing Certified Through	2024-12-31

Package

Package Images

NDC 10267-3846-02 (10267384602)

Pricing Information	N/A
NDC Package Code	10267-3846-2
Billing NDC	10267384602
Package	250 TABLET in 1 BOTTLE (10267-3846-2)
Marketing Start Date	2014-01-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 237bcb87-64a0-415b-bd53-e9d3b8bf33b6 Details

SPL UNCLASSIFIED SECTION

Important: Read all product information before using.

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Drug Facts

ACTIVE INGREDIENT (in each tablet)

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever/fever reducer

USES

Temporarily relieves minor aches and pains due to:

headache
muscular ache
minor pain of arthritis
toothache
backache
the common cold
menstrual cramps
temporarily reduces fever

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 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 non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
have 3 or more alcoholic drinks every day while using this product
take more or for longer time than directed

Heart attack and stroke warning: NSAIDs, except aspirin, increases 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 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 and 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 (1-800-222-1222) right away.

DIRECTIONS

do not take more than directed
the smallest effective dose should be used

Adults and children 12 years of age 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 of age: ■ Ask a doctor

SPL UNCLASSIFIED SECTION

Other information

store between 20˚ to 25˚C (68˚to 77˚F)
avoid excessive heat above 40˚C (104˚F)

INACTIVE INGREDIENTS

(White) Carnauba Wax, Croscarmellose Sodium, Hypromellose, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Povidone, Pregelatinized Starch, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, and Titanium Dioxide.

(Orange) Croscarmellose Sodium, FD&C Yellow #6 Lake, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Pregelatinized Starch, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, Talc and Titanium Dioxide.

(Brown) Croscarmellose Sodium, Hydroxypropylcellulose, Hypromellose, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Pregelatinized Starch, Red Iron Oxide, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, and Titanium Dioxide.

QUESTIONS or COMMENTS?

Call 1-800-231-4670: weekdays 9:00 AM to 5:00 PM EST

SPL UNCLASSIFIED SECTION

**This product is not manufactured or distributed by McNeil, owner of the registered trademark Motrin®IB

Manufactured by:

Contract Pharmacal Corp.

135 Adams Avenue

Hauppauge, NY 11788 USA

www.cpc.com

XXXXX-10-18

Barcode

Peel here for more information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

See New Warnings

CONTRACT PHARMACAL CORP NDC 10267-3909-2

**Compares to the active ingredient in Motrin ®IB

GLUTEN FREE

Ibuprofen Tablets, USP 200 mg

Pain Reliever/Fever Reducer

(NSAID)

250 Coated Tablets

DYE-FREE

NOT ACTUAL SIZE

See New Warnings

CONTRACT PHARMACAL CORP NDC 10267-3846-2

**Compares to the active ingredient in Motrin ®IB

GLUTEN FREE

Ibuprofen Tablets, USP 200 mg

Pain Reliever/Fever Reducer

(NSAID)

250 Coated Tablets

NOT ACTUAL SIZE

See New Warnings

CONTRACT PHARMACAL CORP NDC 10267-3852-2

**Compares to the active ingredient in Motrin ®IB

GLUTEN FREE

Ibuprofen Tablets, USP 200 mg

Pain Reliever/Fever Reducer

(NSAID)

250 Coated Tablets

NOT ACTUAL SIZE

INGREDIENTS AND APPEARANCE

IBUPROFEN

ibuprofen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10267-3852
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
STARCH, CORN (UNII: O8232NY3SJ)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
POVIDONE K30 (UNII: U725QWY32X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
HYPROMELLOSES (UNII: 3NXW29V3WO)

Product Characteristics
Color	brown	Score	no score
Shape	ROUND (convex)	Size	6mm
Flavor		Imprint Code	C1
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10267-3852-2	250 in 1 BOTTLE; Type 0: Not a Combination Product	01/15/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA071265	01/15/2014

IBUPROFEN

ibuprofen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10267-3846
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
STARCH, CORN (UNII: O8232NY3SJ)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
POVIDONE K30 (UNII: U725QWY32X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYVINYL ALCOHOL (UNII: 532B59J990)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND (convex)	Size	6mm
Flavor		Imprint Code	C1
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10267-3846-2	250 in 1 BOTTLE; Type 0: Not a Combination Product	01/15/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA071265	01/15/2014

IBUPROFEN

ibuprofen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10267-3909
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
STARCH, CORN (UNII: O8232NY3SJ)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
POVIDONE K30 (UNII: U725QWY32X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CARNAUBA WAX (UNII: R12CBM0EIZ)

Product Characteristics
Color	white	Score	no score
Shape	ROUND (convex)	Size	6mm
Flavor		Imprint Code	C1
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10267-3909-2	250 in 1 BOTTLE; Type 0: Not a Combination Product	01/15/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA071265	01/15/2014

Labeler - Contract Pharmacal Corp. (057795122)

Registrant - Contract Pharmacal Corp. (057795122)

Name	Address	ID/FEI	Business Operations
Establishment
Contract Pharmacal Corp.		057795122	pack(10267-3852, 10267-3846, 10267-3909)

Name	Address	ID/FEI	Business Operations
Establishment
Contract Pharmacal Corp.		968334974	manufacture(10267-3852, 10267-3846, 10267-3909)

Name	Address	ID/FEI	Business Operations
Establishment
Contract Pharmacal Corp.		968335112	manufacture(10267-3852, 10267-3846, 10267-3909)

Revised: 11/2018

Document Id: 77cf0092-7436-14ba-e053-2991aa0ac112

Set id: 237bcb87-64a0-415b-bd53-e9d3b8bf33b6

Version: 13

Effective Time: 20181107

Search by Drug Name or NDC

NDC 10267-3846-02 ibuprofen 200 mg/1 Details

ibuprofen 200 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 10267-3846-02 (10267384602)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 237bcb87-64a0-415b-bd53-e9d3b8bf33b6 Details

SPL UNCLASSIFIED SECTION

ACTIVE INGREDIENT (in each tablet)

PURPOSE

USES

WARNINGS

DO NOT USE

ASK 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

DIRECTIONS

SPL UNCLASSIFIED SECTION

INACTIVE INGREDIENTS

QUESTIONS or COMMENTS?

SPL UNCLASSIFIED SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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