Label: IBUPROFEN IMMEDIATE RELEASE- ibuprofen tablet, coated
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NDC Code(s):
59556-811-06,
59556-811-08,
59556-811-25,
59556-811-41, view more59556-811-44, 59556-812-06, 59556-812-08, 59556-812-25, 59556-812-41, 59556-812-44
- Packager: Strides Pharma Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 26, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT(S)
- PURPOSE
- USE(S)
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WARNINGS
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
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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
- WHEN USING THIS PRODUCT
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STOP USE AND ASK 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
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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 tablet or caplet every 4 to 6 hours while symptoms persist
- if pain or fever does not respond to 1 tablet or caplet, 2 tablets or caplets may be used
- do not exceed 6 tablets or caplets in 24 hours, unless directed by a doctor
children under 12 years
• ask a doctor
- store between 20 – 25°C (68-77°F)
- do not use if imprinted text "SEALED for YOUR PROTECTION" on the safety seal under cap is broken or missing
- see end panel for lot number and expiration date
- Very low sodium
- Each tablet contains 0.714 mg of Magnesium
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INACTIVE INGREDIENT (S)
colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide and triacetin
QUESTIONS OR COMMENTS?
Call 1-855-742-7868
Manufactured by:
Strides Shasun Limited,
Puducherry - 605 014, India
PON/DRUGS/16134193
Distributed by:
Strides Pharma Inc
East Brunswick, NJ 08816
July 2017
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PRINCIPAL DISPLAY PANEL
Package Label (Round Shaped Tablets) - Principal Display Panel - 24 - Count Bottle, 200 mg Tablets
NDC 59556-811-41
Ibuprofen Tablets USP
200 mg
Pain Reliever/Fever Reducer (NSAID)*
24 Coated Tablets
*nonsteroidal anti-inflammatory drug
Package Label (Capsule Shaped Tablets) - Principal Display Panel - 24 - Count Bottle, 200 mg Tablets
NDC 59556-812-41
Ibuprofen Tablets USP
200 mg
Pain Reliever/Fever Reducer (NSAID)*
24 Coated Caplets**
**capsule-shaped tablets
*nonsteroidal anti-inflammatory drug
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INGREDIENTS AND APPEARANCE
IBUPROFEN IMMEDIATE RELEASE
ibuprofen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59556-812 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) TALC (UNII: 7SEV7J4R1U) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color WHITE Score no score Shape CAPSULE (CAPLET SHAPED) Size 14mm Flavor Imprint Code IBU200 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59556-812-41 1 in 1 CARTON 06/29/2018 1 24 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:59556-812-25 1 in 1 CARTON 06/29/2018 2 50 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:59556-812-06 1 in 1 CARTON 06/29/2018 3 100 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:59556-812-44 1 in 1 CARTON 06/29/2018 4 165 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:59556-812-08 1 in 1 CARTON 06/29/2018 5 1000 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206989 06/29/2018 IBUPROFEN IMMEDIATE RELEASE
ibuprofen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59556-811 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) TALC (UNII: 7SEV7J4R1U) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color WHITE Score no score Shape ROUND (ROUND SHAPED) Size 10mm Flavor Imprint Code IBU200 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59556-811-41 1 in 1 CARTON 06/29/2018 1 24 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:59556-811-25 1 in 1 CARTON 06/29/2018 2 50 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:59556-811-06 1 in 1 CARTON 06/29/2018 3 100 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:59556-811-44 1 in 1 CARTON 06/29/2018 4 165 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:59556-811-08 1 in 1 CARTON 06/29/2018 5 1000 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206989 06/29/2018 Labeler - Strides Pharma Inc (078868278) Registrant - Strides Pharma Global Pte. Ltd. (659220961) Establishment Name Address ID/FEI Business Operations Strides Pharma Science Limited 871402375 ANALYSIS(59556-811, 59556-812) , MANUFACTURE(59556-811, 59556-812) , PACK(59556-811, 59556-812)