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NDC 59779-0393-20 Ibuprofen 200 mg/1 Details

Ibuprofen 200 mg/1

Ibuprofen is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Pharmacy. 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: 59779-0393-20
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ibuprofen

Product Information

NDC	59779-0393
Product ID	59779-393_2400f779-11b8-4e42-ad06-2cec71dfe83f
Associated GPIs	66100020000305
GCN Sequence Number	008346
GCN Sequence Number Description	ibuprofen TABLET 200 MG ORAL
HIC3	S2B
HIC3 Description	NSAIDS, CYCLOOXYGENASE INHIBITOR TYPE ANALGESICS
GCN	35743
HICL Sequence Number	003723
HICL Sequence Number Description	IBUPROFEN
Brand/Generic	Generic
Proprietary Name	Ibuprofen
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ibuprofen
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	200
Active Ingredient Units	mg/1
Substance Name	IBUPROFEN
Labeler Name	CVS Pharmacy
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	ANDA075139
Listing Certified Through	2023-12-31

Package

Package Images

NDC 59779-0393-20 (59779039320)

Pricing Information	N/A
NDC Package Code	59779-393-20
Billing NDC	59779039320
Package	225 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59779-393-20)
Marketing Start Date	1999-03-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 03612ed1-e8dd-4964-b394-7eb613c1df0b Details

Active ingredient (in each orange caplet)

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

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

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

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:

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

right before or after heart surgery
if you have ever had an allergic reaction to any other pain reliever/fever reducer

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
you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
you have problems or serious side effects from taking pain relievers or fever reducers

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

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
- weakness in one part or side of body
- trouble breathing
- slurred speech
- leg swelling
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
any new symptoms appear
redness or swelling is present in the painful area

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 and over: 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

Other information

store between 20º-25ºC (68º-77ºF)
avoid excessive heat 40ºC (104ºF)
see end flap for expiration date and lot number

Inactive ingredients

carnauba wax, colloidal silicon dioxide, corn starch, FD&C yellow #6 aluminum lake, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

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

Principal Display Panel

♥CVSHealth™

Compare to the active ingredient

in Motrin® IB Caplets†

Coated Caplets**

NDC 59779-393-15

Ibuprofen

IBUPROFEN TABLETS USP, 200 mg

Pain reliever, Fever reducer (NSAID)

50 COATED CAPLETS**

**Capsule-shaped tablets

Actual Size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2017 CVS/pharmacy

CVS.com® 1-800-SHOP CVS V-11112

50844

REV1116A39315

†This product is not manufactured or distributed by Johnson & Johnson

Corporation, owner of the registered trademark Motrin® IB Caplets.

CVS 44-393

INGREDIENTS AND APPEARANCE

IBUPROFEN

ibuprofen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59779-393
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
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange	Score	no score
Shape	OVAL	Size	14mm
Flavor		Imprint Code	44;393
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:59779-393-15	1 in 1 CARTON	03/01/1999
1		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:59779-393-20	225 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/01/1999

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA075139	03/01/1999

Labeler - CVS Pharmacy (062312574)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(59779-393)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(59779-393)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(59779-393)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	pack(59779-393)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(59779-393)

Revised: 4/2022

Document Id: 2400f779-11b8-4e42-ad06-2cec71dfe83f

Set id: 03612ed1-e8dd-4964-b394-7eb613c1df0b

Version: 12

Effective Time: 20220408