Label: IBUWIN FORTE- ibuprofen tablet
- NDC Code(s): 69729-157-10
- Packager: OPMX LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 29, 2023
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT (in each tablet/caplet)
- 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
- 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
- the 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 or asthma
- you are taking a diuretic
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
- the risk of heart attack 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 stomach bleeding:
- feel faint
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
- 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
-
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 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
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
IBUWIN FORTE
ibuprofen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69729-157 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 STARCH, CORN (UNII: O8232NY3SJ) POVIDONE K30 (UNII: U725QWY32X) STEARIC ACID (UNII: 4ELV7Z65AP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) TRIACETIN (UNII: XHX3C3X673) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) Product Characteristics Color red (Reddish Brown) Score no score Shape ROUND Size 10mm Flavor Imprint Code G;2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69729-157-10 1 in 1 CARTON 12/29/2023 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079174 12/29/2023 Labeler - OPMX LLC (029918743) Establishment Name Address ID/FEI Business Operations Granules India Limited 918609236 label(69729-157) , manufacture(69729-157)
