Label: OMEPRAZOLE- omeprazole tablet, delayed release
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NDC Code(s):
69230-318-05,
69230-318-10,
69230-318-32,
69230-318-33, view more69230-318-34, 69230-318-35, 69230-318-36, 69230-318-37
- Packager: Camber Consumer Care Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 28, 2022
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)
- 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 a doctor or pharmacist before use if you are
- Stop use and ask a doctor if:
- If pregnant 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 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
colloidal silicon dioxide, crospovidone, glyceryl monostearate, hypromellose, hydroxypropyl cellulose, iron oxide red, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, silicified microcrystalline cellulose, sodium hydroxide, sodium lauryl sulphate, starlac (contains lactose monohydrate and corn starch), sugar spheres (contains sucrose and corn starch), talc, titanium dioxide, triethyl citrate.
- Questions?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OMEPRAZOLE
omeprazole tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69230-318 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE 20 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSPOVIDONE (UNII: 68401960MK) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P) SUCROSE (UNII: C151H8M554) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) FERRIC OXIDE RED (UNII: 1K09F3G675) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color pink Score no score Shape OVAL Size 14mm Flavor Imprint Code H;O9 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69230-318-35 1 in 1 CARTON 03/25/2020 1 14 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:69230-318-36 2 in 1 CARTON 03/25/2020 2 14 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:69230-318-37 3 in 1 CARTON 03/25/2020 3 14 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:69230-318-32 1 in 1 CARTON 03/25/2020 4 14 in 1 BLISTER PACK; Type 0: Not a Combination Product 5 NDC:69230-318-33 2 in 1 CARTON 03/25/2020 5 14 in 1 BLISTER PACK; Type 0: Not a Combination Product 6 NDC:69230-318-34 3 in 1 CARTON 03/25/2020 6 14 in 1 BLISTER PACK; Type 0: Not a Combination Product 7 NDC:69230-318-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 10/29/2020 8 NDC:69230-318-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 10/29/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211732 03/25/2020 Labeler - Camber Consumer Care Inc (079539968) Establishment Name Address ID/FEI Business Operations Hetero Labs Limited Unit III 676162024 manufacture(69230-318)