Label: IBUPROFEN tablet
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NDC Code(s):
62207-365-16,
62207-365-24,
62207-365-25,
62207-365-26, view more62207-365-27, 62207-365-66, 62207-365-67, 62207-365-68, 62207-365-80, 62207-366-24, 62207-366-25, 62207-366-26, 62207-366-27, 62207-366-66, 62207-366-67, 62207-366-68, 62207-366-80
- Packager: Granules India Limited
- Category: BULK INGREDIENT
- DEA Schedule: None
- Marketing Status: Export only
Drug Label Information
Updated December 14, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- 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
- 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, or kidney disease
■ you have asthma
■ you are taking a diuretic
- ASK A DOCTOR OR PHARMACIST
- WHEN USING
-
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
■ pain gets worse or lasts more than 10 days
■ fever gets worse or lasts more than 3 days
■ redness or swelling id present in the painful area
■ any new symptoms appear
- IF PREGNANT OR BREAST-FEEDING
- 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 a caplet every 4 to 6 hours while symptoms persist
■ if pain or fever dose not respond to 1 tablet, 2 tablets may be used
■ do not exceed 6 tablets in 24 hours , unless directed by a doctorchilder under 12 years ■ ask a doctor - SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tabletProduct Information Product Type BULK INGREDIENT Item Code (Source) NDC:62207-365 Route of Administration NOT APPLICABLE 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) HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K) TRIACETIN (UNII: XHX3C3X673) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) DEXTROSE MONOHYDRATE (UNII: LX22YL083G) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) MALTODEXTRIN (UNII: 7CVR7L4A2D) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) Product Characteristics Color red 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:62207-365-24 48000 in 1 BOX 01/01/2011 2 NDC:62207-365-25 71000 in 1 BOX 01/01/2011 3 NDC:62207-365-26 80000 in 1 BOX 01/01/2011 4 NDC:62207-365-27 97000 in 1 BOX 01/01/2011 5 NDC:62207-365-66 258000 in 1 DRUM 01/01/2011 6 NDC:62207-365-67 190476 in 1 DRUM 01/01/2011 7 NDC:62207-365-80 258000 in 1 DRUM 01/01/2011 8 NDC:62207-365-68 175000 in 1 BOX 01/01/2011 9 NDC:62207-365-16 258899 in 1 DRUM 11/10/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Export only 01/01/2011 IBUPROFEN
ibuprofen tabletProduct Information Product Type BULK INGREDIENT Item Code (Source) NDC:62207-366 Route of Administration NOT APPLICABLE 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) HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K) TRIACETIN (UNII: XHX3C3X673) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) DEXTROSE MONOHYDRATE (UNII: LX22YL083G) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) MALTODEXTRIN (UNII: 7CVR7L4A2D) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) Product Characteristics Color red Score no score Shape OVAL (caplet) Size 14mm Flavor Imprint Code G;2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62207-366-24 48000 in 1 BOX 01/01/2011 2 NDC:62207-366-25 71000 in 1 BOX 01/01/2011 3 NDC:62207-366-26 80000 in 1 BOX 01/01/2011 4 NDC:62207-366-27 97000 in 1 BOX 01/01/2011 5 NDC:62207-366-66 258000 in 1 DRUM 01/01/2011 6 NDC:62207-366-67 190476 in 1 DRUM 01/01/2011 7 NDC:62207-366-80 258000 in 1 DRUM 01/01/2011 8 NDC:62207-366-68 175000 in 1 BOX 01/01/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Export only 01/01/2011 Labeler - Granules India Limited (915000087) Registrant - Granules India Limited (915000087) Establishment Name Address ID/FEI Business Operations Granules India Limited 918609236 manufacture(62207-365, 62207-366)