Label: AMAZON BASIC CARE IBUPROFEN- ibuprofen tablet
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NDC Code(s):
72288-513-10,
72288-513-11,
72288-513-20,
72288-513-49, view more72288-513-50
- Packager: Amazon.com Services LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 14, 2024
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
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you have symptoms of heart problems or stroke:
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chest pain
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trouble breathing
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weakness in one part or side of body
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slurred speech
- leg swelling
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- 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 tablet every 4 to 6 hours while symptoms persist
- if pain or fever does not respond to 1 tablet, 2 tablets may be used
- do not exceed 6 tablets 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 1-855-274-4122
DISTRIBUTED BY:
AMAZON.COM SERVICES LLC
410 TERRY AVENUE N., SEATTLE, WA 98109
Made in India - 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
AMAZON BASIC CARE IBUPROFEN
ibuprofen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72288-513 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 ROUND Size 10mm Flavor Imprint Code N;II Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72288-513-10 1 in 1 CARTON 05/15/2024 1 100 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:72288-513-20 1 in 1 CARTON 05/15/2024 2 200 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:72288-513-49 500 in 1 BOTTLE; Type 0: Not a Combination Product 05/15/2024 4 NDC:72288-513-50 500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/15/2024 5 NDC:72288-513-11 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/15/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208865 05/15/2024 Labeler - Amazon.com Services LLC (128990418) Registrant - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations Aurobindo Pharma Limited 650381903 ANALYSIS(72288-513) , MANUFACTURE(72288-513) Establishment Name Address ID/FEI Business Operations APL HEALTHCARE LIMITED 650844777 ANALYSIS(72288-513) , MANUFACTURE(72288-513)