Label: IBUPROFEN tablet
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NDC Code(s):
58602-713-01,
58602-713-02,
58602-713-03,
58602-713-05, view more58602-713-06, 58602-713-07, 58602-713-08, 58602-713-09, 58602-713-10, 58602-713-15, 58602-713-34, 58602-713-36, 58602-713-40, 58602-713-41, 58602-713-45, 58602-713-48, 58602-713-49, 58602-713-52, 58602-713-53, 58602-713-56, 58602-713-57, 58602-713-58, 58602-713-59, 58602-713-63, 58602-713-71, 58602-713-73, 58602-713-75, 58602-713-83, 58602-713-86, 58602-713-87
- Packager: Aurohealth LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 23, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Purposes
- 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 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 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
- you experience any of the following signs of stomach bleeding:
- 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 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
- Other information
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Inactive ingredients
colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, microcrystalline cellulose, polyethylene glycol, red iron oxide, stearic acid, titanium dioxide and yellow iron oxide
Questions or comments?
Call 1-855-274-4122Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Made in India
Code: TS/DRUGS/16/2014
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (100 Tablets Bottle)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (100 Tablets Container Carton)
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INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-713 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) STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) FERRIC OXIDE RED (UNII: 1K09F3G675) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Product Characteristics Color BROWN (Light Brown to Brown) Score no score Shape CAPSULE (Biconvex) Size 15mm Flavor Imprint Code N;I Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58602-713-73 1 in 1 CARTON 03/22/2022 1 24 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:58602-713-57 1 in 1 CARTON 03/22/2022 2 40 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:58602-713-09 1 in 1 CARTON 03/22/2022 3 50 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:58602-713-10 1 in 1 CARTON 03/22/2022 4 60 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:58602-713-56 1 in 1 CARTON 03/22/2022 5 90 in 1 BOTTLE; Type 0: Not a Combination Product 6 NDC:58602-713-07 1 in 1 CARTON 03/22/2022 6 100 in 1 BOTTLE; Type 0: Not a Combination Product 7 NDC:58602-713-53 1 in 1 CARTON 03/22/2022 7 150 in 1 BOTTLE; Type 0: Not a Combination Product 8 NDC:58602-713-83 1 in 1 CARTON 03/22/2022 8 200 in 1 BOTTLE; Type 0: Not a Combination Product 9 NDC:58602-713-59 225 in 1 BOTTLE; Type 0: Not a Combination Product 03/22/2022 10 NDC:58602-713-71 250 in 1 BOTTLE; Type 0: Not a Combination Product 03/22/2022 11 NDC:58602-713-49 300 in 1 BOTTLE; Type 0: Not a Combination Product 03/22/2022 12 NDC:58602-713-48 500 in 1 BOTTLE; Type 0: Not a Combination Product 03/22/2022 13 NDC:58602-713-63 550 in 1 BOTTLE; Type 0: Not a Combination Product 03/22/2022 14 NDC:58602-713-86 750 in 1 BOTTLE; Type 0: Not a Combination Product 03/22/2022 15 NDC:58602-713-58 1000 in 1 BOTTLE; Type 0: Not a Combination Product 03/22/2022 16 NDC:58602-713-45 1500 in 1 BOTTLE; Type 0: Not a Combination Product 03/22/2022 17 NDC:58602-713-01 1 in 1 CARTON 03/22/2022 17 24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 18 NDC:58602-713-05 1 in 1 CARTON 03/22/2022 18 40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 19 NDC:58602-713-08 1 in 1 CARTON 03/22/2022 19 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 20 NDC:58602-713-15 1 in 1 CARTON 03/22/2022 20 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 21 NDC:58602-713-06 1 in 1 CARTON 03/22/2022 21 90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 22 NDC:58602-713-02 1 in 1 CARTON 03/22/2022 22 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 23 NDC:58602-713-03 1 in 1 CARTON 03/22/2022 23 150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 24 NDC:58602-713-34 200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/22/2022 25 NDC:58602-713-36 250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/22/2022 26 NDC:58602-713-75 300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/22/2022 27 NDC:58602-713-40 500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/22/2022 28 NDC:58602-713-87 550 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/22/2022 29 NDC:58602-713-52 700 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/22/2022 30 NDC:58602-713-41 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/22/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208865 03/22/2022 Labeler - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations APL HEALTHCARE LIMITED 650844777 ANALYSIS(58602-713) , MANUFACTURE(58602-713) Establishment Name Address ID/FEI Business Operations Aurobindo Pharma Limited 650381903 ANALYSIS(58602-713) , MANUFACTURE(58602-713)