Timely 731R Omeprazole 20mg Tablets
- Manufacturer
- TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
- Effective date
- 2025-11-22
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:22:57
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet)
Omeprazole, USP 20 mg
(equivalent to 20.6 mg omeprazole magnesium)
OTC - PURPOSE SECTION
Purpose
Acid reducer
INDICATIONS & USAGE SECTION
Uses
- treats frequent heartburn (occurs 2 or more days a week)
- not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect
WARNINGS SECTION
Warnings
Allergy alert:
- Do not use if you are allergic to Omeprazole
- Omeprazole may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If an allergic reaction occurs, stop use and seek medical attention right away.
OTC - DO NOT USE SECTION
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.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have:
- had heartburn over 3 months. This may be a sign of a more serious condition.
- frequent wheezing, particularly with heartburn
- unexplained weight loss
- nausea or vomiting
- stomach pain
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking a prescription drug.
Acid reducers may interact with certain prescription drugs.
OTC - STOP USE SECTION
Stop use and ask a doctor if
- your heartburn continues or worsens
- you need to take this product for more than 14 days
- you need to take more than 1 course of treatment every 4 months
- you get diarrhea
- you develop a rash or joint pain
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
DOSAGE & ADMINISTRATION SECTION
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 SAFETY INFORMATION
Other information
- read the directions and warnings before use
- keep the carton. It contains important information.
- store at 20-25°C (68-77°F) and protect from moisture
INACTIVE INGREDIENT SECTION
Inactive ingredients
colloidal silicone dioxide, crospovidone, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 6000, polysorbate 80, red iron oxide, simethicone, sodium stearyl fumarate, starch, sucrose, talc, titanium dioxide, triethyl citrate
OTC - QUESTIONS SECTION
Questions or comments? Call 1-877-290-4008
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
731R Omezprazole 20mg Tablets IFC
731R Omeprazole 20mg Tablets Label
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| OMEPRAZOLE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0349483731415 | GTIN-13: 0349483731415 EAN-13: 0349483731415 GTIN-12: 349483731415 UPC-A: 349483731415 GTIN storage (14 digits): 00349483731415 | 731R IFC.jpg |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| dc7c5daa-021f-40dd-b00d-63982cb2067a | Product name | 1 | 20230426 |
| 873ef493-6b37-49d8-ac7f-bfca4117d2c1 | Product name | 5 | 20210607 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 5 | 20200925 |
| f33561b9-47cb-411c-a228-16c62e346cd4 | Product name | 1 | 20200415 |
| ade821ba-260a-47e2-bd89-743e27ac9906 | Product name | 1 | 20161121 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 2 | 20160823 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49483-731-41 | Omeprazole delayed release | 3 in 1 CARTON | TABLET, DELAYED RELEASE | 3 | 2 | |
| 49483-731-45 | Omeprazole delayed release | 14 in 1 BOTTLE | TABLET, DELAYED RELEASE | 14 | 2 |
Products#
Every source-derived product name is available through these pages.
- Omeprazole delayed release
- Omeprazole 20mg
- TRIETHYL CITRATE
- GLYCERYL MONOSTEARATE
- MAGNESIUM STEARATE
- METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
- SODIUM STEARYL FUMARATE
- TITANIUM DIOXIDE
- STARCH, CORN
- HYPROMELLOSE, UNSPECIFIED
- POLYETHYLENE GLYCOL 6000
- SUCROSE
- TALC
- MICROCRYSTALLINE CELLULOSE
- POLYSORBATE 80
- FERRIC OXIDE RED
- DIMETHICONE, UNSPECIFIED
- OMEPRAZOLE MAGNESIUM
- OMEPRAZOLE
- POLYETHYLENE GLYCOL 400
- SILICON DIOXIDE
- CROSPOVIDONE, UNSPECIFIED
- HYDROXYPROPYL CELLULOSE, UNSPECIFIED
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 49483-731 | 49483-731-45, 49483-731-41 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A218829-001 | OMEPRAZOLE MAGNESIUM | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2025-08-07 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A218829-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2025-08-07 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A218829-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2025-08-07 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A218829-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2025-08-07 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A218829-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2025-08-07 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218829-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2025-08-07 | 31067a03dcf5… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218829-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2025-08-07 | a50c72e98297… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Omeprazole delayed release | OMEPRAZOLE 20MG | TIME CAP LABORATORIES, INC. | 40906798-cd84-fbd0-e063-6294a90a1d29 | 2025-11-22 | Warnings | 49483-731-45 49483-731-41 49483-731 49483073141 49483073145 442e2a90-4ac6-8adf-e063-6394a90a6fc2 40906798-cd84-fbd0-e063-6294a90a1d29 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

