Label: IBUPROFEN capsule, liquid filled
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NDC Code(s):
59556-764-11,
59556-764-12,
59556-764-13,
59556-764-18, view more59556-764-29, 59556-764-48, 59556-764-49, 59556-764-50, 59556-764-92, 59556-895-13, 59556-895-29, 59556-895-39, 59556-895-48, 59556-895-50, 59556-895-79, 59556-895-85, 59556-895-86, 59556-895-87, 59556-895-88
- Packager: Strides Pharma Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 15, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each capsule)
- Purpose
- Uses
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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 aged 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
- 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
- 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
- take with food or milk if stomach upset occurs
- 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 at 20 weeks or later in 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
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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
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Inactive ingredients
FD&C blue 1, gelatin, gelatin (hydrolyzed), medium chain triglyceride, PEG 600, potassium hydroxide, purified water, sorbital and sorbitan solution.
Printing ink: propylene glycol, shellac resins, sodium lauryl sulphate, titanium dioxide.
Ibuprofen Capsules – Minis
FD&C green no.3, gelatin, gelatin (hydrolyzed), lecithin (Soya Lecithin), medium chain triglyceride, polyethylene Glycol 600, potassium hydroxide, purified water, sorbital and sorbitan solution.
Printing ink: propylene glycol, shellac resins, sodium lauryl sulphate, titanium dioxide.
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Questions or comments?
Do Not Use if seal under bottle cap imprinted with "SEALED for YOUR PROTECTION" is broken or missing.
For most recent product information, visit us at www.strides.com
Revised: 05/2023
Manufactured by:
Strides Pharma Science Limited
Bengaluru - 562106, India
Distributed by:
Strides Pharma Inc.
East Brunswick, NJ 08816
- PRINCIPAL DISPLAY PANELS
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INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59556-764 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 POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) WATER (UNII: 059QF0KO0R) GELATIN (UNII: 2G86QN327L) SORBITOL (UNII: 506T60A25R) SORBITAN (UNII: 6O92ICV9RU) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color GREEN (transparent green to bluish green) Score no score Shape OVAL (oblong shaped) Size 8mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59556-764-29 1 in 1 CARTON 11/16/2022 1 20 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:59556-764-12 1 in 1 CARTON 11/16/2022 2 40 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:59556-764-13 1 in 1 CARTON 11/16/2022 3 80 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:59556-764-11 1 in 1 CARTON 11/16/2022 4 120 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:59556-764-48 1 in 1 CARTON 11/16/2022 5 160 in 1 BOTTLE; Type 0: Not a Combination Product 6 NDC:59556-764-49 1 in 1 CARTON 11/16/2022 6 200 in 1 BOTTLE; Type 0: Not a Combination Product 7 NDC:59556-764-50 1 in 1 CARTON 11/16/2022 7 300 in 1 BOTTLE; Type 0: Not a Combination Product 8 NDC:59556-764-18 1 in 1 CARTON 11/16/2022 8 180 in 1 BOTTLE; Type 0: Not a Combination Product 9 NDC:59556-764-92 3000 in 1 BAG; Type 0: Not a Combination Product 11/16/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204469 11/16/2022 IBUPROFEN
ibuprofen capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59556-895 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 POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) WATER (UNII: 059QF0KO0R) GELATIN (UNII: 2G86QN327L) SORBITOL (UNII: 506T60A25R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) SORBITAN (UNII: 6O92ICV9RU) Product Characteristics Color GREEN (transparent green to bluish green) Score no score Shape OVAL Size 8mm Flavor Imprint Code 469 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59556-895-29 1 in 1 CARTON 11/16/2022 1 20 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:59556-895-13 1 in 1 CARTON 11/16/2022 2 80 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:59556-895-48 1 in 1 CARTON 11/16/2022 3 160 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:59556-895-50 1 in 1 CARTON 11/16/2022 4 300 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:59556-895-79 7000 in 1 BAG; Type 0: Not a Combination Product 11/16/2022 6 NDC:59556-895-85 1 in 1 CARTON 11/16/2022 6 80 in 1 BOTTLE; Type 0: Not a Combination Product 7 NDC:59556-895-86 1 in 1 CARTON 11/16/2022 7 120 in 1 BOTTLE; Type 0: Not a Combination Product 8 NDC:59556-895-87 1 in 1 CARTON 11/16/2022 8 160 in 1 BOTTLE; Type 0: Not a Combination Product 9 NDC:59556-895-39 1 in 1 CARTON 11/16/2022 9 200 in 1 BOTTLE; Type 0: Not a Combination Product 10 NDC:59556-895-88 1 in 1 CARTON 11/16/2022 10 300 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 ANDA204469 11/16/2022 Labeler - Strides Pharma Inc (078868278)