- Drug Facts
- Purpose
- Uses
-
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 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. - Do not use
-
Ask a doctor before use if
- stomach bleeding warning applies to you
- you have problems or serious side effects from taking pain relievers or fever reducers
- 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
- When using this product
-
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.
- you experience any of the following signs of stomach bleeding:
- Keep out of reach of children.
-
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 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
- Other information
-
Inactive ingredients
black iron oxide, FD & C green no. 3, gelatin, hypromellose, polyethylene glycol, potassium hydroxide, propylene glycol, sorbitol sorbitan solution
Questions or comments?
call 1-855-274-4122
Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648
Made in India
Code No.: TS/DRUGS/22/2009
Issued: August 2017 - PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (40 Capsules Bottle)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (40 Capsules Container Carton)
-
INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-902 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg Inactive Ingredients Ingredient Name Strength FERROSOFERRIC OXIDE (UNII: XM0M87F357) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITOL (UNII: 506T60A25R) 1,4-SORBITAN (UNII: AV0YTZ4E6J) MANNITOL (UNII: 3OWL53L36A) WATER (UNII: 059QF0KO0R) ISOPROPYL ALCOHOL (UNII: ND2M416302) Product Characteristics Color GREEN Score no score Shape RECTANGLE (Oblong) Size 19mm Flavor Imprint Code I200 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58602-902-73 1 in 1 CARTON 06/29/2018 1 20 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:58602-902-12 1 in 1 CARTON 06/29/2018 2 40 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:58602-902-18 1 in 1 CARTON 06/29/2018 3 80 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:58602-902-30 160 in 1 BOTTLE; Type 0: Not a Combination Product 06/29/2018 5 NDC:58602-902-38 300 in 1 BOTTLE; Type 0: Not a Combination Product 06/29/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207753 06/29/2018 Labeler - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations APL HEALTHCARE LIMITED 650844777 ANALYSIS(58602-902) , MANUFACTURE(58602-902) Establishment Name Address ID/FEI Business Operations Aurobindo Pharma Limited 650381903 ANALYSIS(58602-902) , MANUFACTURE(58602-902)