NDC | 59556-805-06, 59556-805-08, 59556-805-41, 59556-806-06, 59556-806-08, 59556-806-41 |
Set ID | 8ad91d2f-8f49-444a-bc1b-07a4f9ef5aed |
Category | Human OTC Drug Label |
Packager | Strides Pharma Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | ANDA207052 |
- ACTIVE INGREDIENT(S)
- PURPOSE
- USE(S)
-
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
- 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
- WHEN USING THIS PRODUCT
-
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 3days
- 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 ibuprofenduring 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 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
OTHER INFORMATION
- 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
- Sodium free
- Each tablet contains 0.714mg of Magnesium
-
INACTIVE INGREDIENT (S)
colloidal silicon dioxide, corn starch, D&C yellow no.10 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide and triacetin
QUESTIONS OR COMMENTS?
Call 1-855-742-7868 (toll-free)
MADE IN INDIA
Mfg.Lic.NO. : PON/DRUGS/16 13 4193
NUPRIN® is a registered trademark of Strides Pharma, Inc.
Manufactured for:
Strides Pharma Inc.
East Brunswick, NJ 08816
www.nuprin.com
August 2017 -
PRINCIPAL DISPLAY PANEL
Package Label (Round Shaped Tablets) - Principal Display Panel - 100 - Count Bottle Carton, 200 mg Tablets
See New Warnings
NDC 59556-805-06
100 Coated Tablets
Nuprin®
Ibuprofen Tablets, USP 200 mg
Pain Reliever/Fever Reducer (NSAID)*
*nonsteroidal anti-inflammatory drugPackage Label (Round Shaped Tablets) - Principal Display Panel - 100 - Count Bottle Label, 200 mg Tablets
Do not use if imprinted safety seal
under cap is broken or missingNDC 59556-805-06
100 Coated TabletsNuprin®
Ibuprofen Tablets, USP 200 mg
Pain Reliever/Fever Reducer (NSAID)*
Important: Read all product information before
using. Keep the box for important information
*nonsteroidal anti-inflammatory drug -
INGREDIENTS AND APPEARANCE
IBUPROFEN IMMEDIATE RELEASE
ibuprofen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59556-806 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) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) 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) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) Product Characteristics Color YELLOW Score no score Shape CAPSULE (CAPLET SHAPED) Size 14mm Flavor Imprint Code N Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59556-806-41 1 in 1 CARTON 08/26/2016 1 24 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:59556-806-06 1 in 1 CARTON 08/26/2016 2 100 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:59556-806-08 1 in 1 CARTON 08/26/2016 3 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 ANDA207052 08/26/2016 IBUPROFEN IMMEDIATE RELEASE
ibuprofen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59556-805 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) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) 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) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) Product Characteristics Color YELLOW Score no score Shape ROUND (ROUND SHAPED) Size 10mm Flavor Imprint Code N Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59556-805-41 1 in 1 CARTON 08/26/2016 1 24 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:59556-805-06 1 in 1 CARTON 08/26/2016 2 100 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:59556-805-08 1 in 1 CARTON 08/26/2016 3 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 ANDA207052 08/26/2016 Labeler - Strides Pharma Inc. (078868278) Establishment Name Address ID/FEI Business Operations Strides Shasun Limited 871402375 MANUFACTURE(59556-805, 59556-806)