Label: IBUPROFEN tablet
-
NDC Code(s):
62207-365-41,
62207-365-42,
62207-365-43,
62207-365-46, view more62207-365-47, 62207-365-48, 62207-365-49, 62207-365-51, 62207-366-41, 62207-366-42, 62207-366-43, 62207-366-46, 62207-366-47, 62207-366-48, 62207-366-49, 62207-366-51, 62207-395-41, 62207-395-42, 62207-395-43, 62207-395-46, 62207-395-47, 62207-395-48, 62207-395-49, 62207-395-51, 62207-396-41, 62207-396-42, 62207-396-43, 62207-396-46, 62207-396-47, 62207-396-48, 62207-396-49, 62207-396-51
- Packager: Granules India Limited
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 30, 2023
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 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
-
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
-
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
- 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,
- 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 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
- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- SPL UNCLASSIFIED SECTION
-
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC# 62207-366-46See New Warnings Information
IBUPROFEN TABLETS USP, 200 mg
Pain Reliever/Fever Reducer (NSAID)*Contains no ingredient made from a
gluten-containing grain (wheat, barley, or rye)Do not use if foil inner seal is broken or missing.
250 Coated Caplets †
†Capsule-Shaped Tablets
Important: Read all product information before using.
Do not use if the foil inner seal is broken or missing
NDC# 62207-366-47
Do not use if the foil inner seal is broken or missing
See New Warnings InformationIBUPROFEN TABLETS USP, 200 mg
Pain Reliever/Fever Reducer (NSAID)*Contains no ingredient made from a
gluten-containing grain (wheat, barley, or rye)Do not use if foil inner seal is broken or missing.
500 Coated Caplets†
†Capsule-Shaped Tablets
Important: Read all product information before using.
NDC# 62207-396-46See New Warnings Information
IBUPROFEN TABLETS USP, 200 mg
Pain Reliever/Fever Reducer (NSAID)*Contains no ingredient made from a
gluten-containing grain (wheat, barley, or rye)Do not use if foil inner seal is broken or missing.
250 Coated Caplets†
†Capsule-Shaped Tablets
Important: Read all product information before using.
NDC# 62207-396-46Do not use if the foil inner seal is broken or missing
See New Warnings Information
IBUPROFEN TABLETS USP, 200 mg
Pain Reliever/Fever Reducer (NSAID)*Contains no ingredient made from a
gluten-containing grain (wheat, barley, or rye)Do not use if foil inner seal is broken or missing.
500 Coated Caplets†
†Capsule-Shaped Tablets
Important: Read all product information before using.
-
INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62207-365 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) TALC (UNII: 7SEV7J4R1U) POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95) 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:62207-365-51 10 in 1 BOTTLE; Type 0: Not a Combination Product 08/13/2019 2 NDC:62207-365-41 24 in 1 BOTTLE; Type 0: Not a Combination Product 08/13/2019 3 NDC:62207-365-42 50 in 1 BOTTLE; Type 0: Not a Combination Product 08/13/2019 4 NDC:62207-365-43 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/13/2019 5 NDC:62207-365-46 250 in 1 BOTTLE; Type 0: Not a Combination Product 08/13/2019 6 NDC:62207-365-47 500 in 1 BOTTLE; Type 0: Not a Combination Product 08/13/2019 7 NDC:62207-365-48 750 in 1 BOTTLE; Type 0: Not a Combination Product 08/13/2019 8 NDC:62207-365-49 1000 in 1 BOTTLE; Type 0: Not a Combination Product 08/13/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079174 01/01/2011 IBUPROFEN
ibuprofen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62207-366 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 POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95) 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) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color red (Reddish Brown) Score no score Shape OVAL ((Capsule shaped tablet)) Size 14mm Flavor Imprint Code G;2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62207-366-51 10 in 1 BOTTLE; Type 0: Not a Combination Product 08/13/2019 2 NDC:62207-366-41 24 in 1 BOTTLE; Type 0: Not a Combination Product 08/13/2019 3 NDC:62207-366-42 50 in 1 BOTTLE; Type 0: Not a Combination Product 08/13/2019 4 NDC:62207-366-43 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/13/2019 5 NDC:62207-366-46 250 in 1 BOTTLE; Type 0: Not a Combination Product 08/13/2019 6 NDC:62207-366-47 500 in 1 BOTTLE; Type 0: Not a Combination Product 08/13/2019 7 NDC:62207-366-48 750 in 1 BOTTLE; Type 0: Not a Combination Product 08/13/2019 8 NDC:62207-366-49 1000 in 1 BOTTLE; Type 0: Not a Combination Product 08/13/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079174 01/01/2011 IBUPROFEN
ibuprofen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62207-396 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) POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color red (Reddish Brown) Score no score Shape OVAL ((Capsule shaped tablet)) Size 14mm Flavor Imprint Code G;2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62207-396-51 10 in 1 BOTTLE; Type 0: Not a Combination Product 08/13/2019 2 NDC:62207-396-41 24 in 1 BOTTLE; Type 0: Not a Combination Product 08/13/2019 3 NDC:62207-396-42 50 in 1 BOTTLE; Type 0: Not a Combination Product 08/13/2019 4 NDC:62207-396-43 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/13/2019 5 NDC:62207-396-46 250 in 1 BOTTLE; Type 0: Not a Combination Product 08/13/2019 6 NDC:62207-396-47 500 in 1 BOTTLE; Type 0: Not a Combination Product 08/13/2019 7 NDC:62207-396-48 750 in 1 BOTTLE; Type 0: Not a Combination Product 08/13/2019 8 NDC:62207-396-49 1000 in 1 BOTTLE; Type 0: Not a Combination Product 08/13/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079174 08/13/2019 IBUPROFEN
ibuprofen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62207-395 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) TALC (UNII: 7SEV7J4R1U) POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95) 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:62207-395-51 10 in 1 BOTTLE; Type 0: Not a Combination Product 08/13/2019 2 NDC:62207-395-41 24 in 1 BOTTLE; Type 0: Not a Combination Product 08/13/2019 3 NDC:62207-395-42 50 in 1 BOTTLE; Type 0: Not a Combination Product 08/13/2019 4 NDC:62207-395-43 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/13/2019 5 NDC:62207-395-46 250 in 1 BOTTLE; Type 0: Not a Combination Product 08/13/2019 6 NDC:62207-395-47 500 in 1 BOTTLE; Type 0: Not a Combination Product 08/13/2019 7 NDC:62207-395-48 750 in 1 BOTTLE; Type 0: Not a Combination Product 08/13/2019 8 NDC:62207-395-49 1000 in 1 BOTTLE; Type 0: Not a Combination Product 08/13/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079174 08/13/2019 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, 62207-395, 62207-396)