Label: AMAZON BASIC CARE OMEPRAZOLE- omeprazole tablet, delayed release
- NDC Code(s): 72288-409-01, 72288-409-03, 72288-409-05, 72288-409-61
- Packager: Amazon.com Services LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 10, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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Tips for Managing Heartburn
- Do not lie flat or bend over after eating
- Do not wear tight-fitting clothing around the stomach
- Do not eat before bedtime
- Raise the head of your bed
- Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol and certain fruits and vegetables
- Eat slowly and avoid big meals
- If overweight, lose weight
- Quit smoking
- Drug Facts
- Active ingredient (in each tablet)
- Purpose
- Use
- Warnings
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Do not use if you have:
- trouble or pain swallowing food, vomiting with blood, or bloody or black stools
- heartburn with lightheadedness, sweating or dizziness
- chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
- frequent chest pain.
These may be signs of a serious condition. See your doctor.
- Ask a doctor before use if you have:
- ASK DOCTOR/PHARMACIST
- Stop use and ask a doctor if:
- PREGNANCY OR BREAST FEEDING
- Keep out of reach of children.
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Directions
- for adults 18 years of age and older
- this product is to be used once a day (every 24 hours), every day for 14 days
- it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours
14-Day Course of Treatment
- swallow 1 tablet with a glass of water before eating in the morning
- take every day for 14 days
- do not take more than 1 tablet a day
- do not use for more than 14 days unless directed by your doctor
- swallow whole.
Do not chew or crush tablets.
Repeated 14-Day Courses (if needed)
- you may repeat a 14-day course every 4 months
- do not take for more than 14 days or more often than every 4 months unless directed by a doctor
- children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.
- Other information
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Inactive ingredients
crospovidone, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, polyethylene glycol, polysorbate 80, red iron oxide, silicified microcrystalline cellulose, sodium hydroxide, sodium stearyl fumarate, sugar spheres [which contains liquid glucose, starch (maize) and sucrose], talc, titanium dioxide, triethyl citrate and yellow iron oxide.
- Questions?
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablet Bottle)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg Container Carton Label
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PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg Blister Carton Label
amazon
basic+careAcid Reducer NDC 72288-409-01
Compare to
Prilosec OTC®
active
ingredient*See current Drug Facts
Omeprazole
Delayed-Release Tablets 20 mgAcid Reducer
Treats Frequent Heartburn!
24 HR
actual size One 14-day course of treatment
May take 1 to 4 days for full effect14 (1 x 14) TABLETS
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INGREDIENTS AND APPEARANCE
AMAZON BASIC CARE OMEPRAZOLE
omeprazole tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72288-409 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEPRAZOLE MAGNESIUM (UNII: 426QFE7XLK) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE 20 mg Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (35 .MU.M) (UNII: 40UAA97IT9) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F) HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4) MAGNESIUM STEARATE (UNII: 70097M6I30) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95) POLYSORBATE 80 (UNII: 6OZP39ZG8H) FERRIC OXIDE RED (UNII: 1K09F3G675) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) STARCH, CORN (UNII: O8232NY3SJ) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYDROXYPROPYL CELLULOSE (45000 WAMW) (UNII: 8VAB711C5E) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) Product Characteristics Color PINK Score no score Shape RECTANGLE (Oblong) Size 14mm Flavor Imprint Code Z;69 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72288-409-05 1 in 1 CARTON 05/15/2024 1 14 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:72288-409-01 1 in 1 CARTON 05/15/2024 2 14 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:72288-409-61 2 in 1 CARTON 05/15/2024 3 14 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:72288-409-03 3 in 1 CARTON 05/15/2024 4 14 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206877 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(72288-409) , MANUFACTURE(72288-409)
