SPL v22
SPL
SPL Set ID 0e8fde83-a55c-edaf-3c66-e1fc77d0bc11
Route
ORAL
Published
Effective Date 2022-11-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Omeprazole (20 mg)
Inactive Ingredients
Ferrosoferric Oxide Anhydrous Dibasic Calcium Phosphate Carrageenan Glyceryl Monostearate Hypromelloses Hypromellose 2208 (3 Mpa.s) Magnesium Oxide Magnesium Stearate Methacrylic Acid - Methyl Methacrylate Copolymer (1:2) Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A Cellulose, Microcrystalline Potassium Chloride Potassium Hydroxide Propylene Glycol Ferric Oxide Red Shellac Silicon Dioxide Raw Sugar Talc Titanium Dioxide Triethyl Citrate

Identifiers & Packaging

Marketing Status
ANDA Active Since 2010-03-01

Description

Drug Facts

Purpose

Acid reducer


Medication Information

Purpose

Acid reducer

Description

Drug Facts

Use

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

Section 42229-5

Drug Facts

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

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 help right away.
Questions

call 1-888-375-3784

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 capsule with a glass of water before eating in the morning

  • take every day for 14 days

  • do not take more than 1 capsule a day

  • do not use for more than 14 days unless directed by your doctor

  • swallow whole. Do not chew or crush capsules.

  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.

Bottle Label

Dr.Reddy's

NDC 55111-397-52

Treats Frequent Heartburn! 24 HR

Omeprazole

Delayed Release- Capsules

20 mg*

ACID REDUCER

14 Capsules(Safety Sealed)

One 14-Day Course of Treatment

May take 1 to 4 days for full effect



Carton Label

Dr.Reddy's

NDC 55111-397-52

Compare to the active ingredient in Prilosec OTC® **

Treats Frequent Heartburn! 24 HR

Omeprazole

Delayed Release- Capsules

20 mg*

ACID REDUCER

14 Capsules(Safety Sealed)

One 14-Day Course of Treatment

May take 1 to 4 days for full effect

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 Ingredients

black iron oxide, dibasic calcium phosphate, gelatin, glyceryl monostearate, hypromellose 3 cps, magnesium oxide, magnesium stearate, methacrylic acid copolymer dispersion, methacrylic acid copolymer Type B, microcrystalline cellulose, polysorbate 80, potassium hydroxide, propylene glycol, red iron oxide, shellac, silicon dioxide, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate

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.

Stop Use and Ask 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

 

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

Revised: 10/2022

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Active Ingredient (in Each Capsule)

*Omeprazole delayed-release capsules 20 mg (equivalent to 20.6 mg omeprazole magnesium)

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug.

Acid reducers may interact with certain prescription drugs.


Structured Label Content

Use

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

Section 42229-5 (42229-5)

Drug Facts

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Acid reducer

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 help right away.
Questions

call 1-888-375-3784

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 capsule with a glass of water before eating in the morning

  • take every day for 14 days

  • do not take more than 1 capsule a day

  • do not use for more than 14 days unless directed by your doctor

  • swallow whole. Do not chew or crush capsules.

  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.

Bottle Label

Dr.Reddy's

NDC 55111-397-52

Treats Frequent Heartburn! 24 HR

Omeprazole

Delayed Release- Capsules

20 mg*

ACID REDUCER

14 Capsules(Safety Sealed)

One 14-Day Course of Treatment

May take 1 to 4 days for full effect



Carton Label

Dr.Reddy's

NDC 55111-397-52

Compare to the active ingredient in Prilosec OTC® **

Treats Frequent Heartburn! 24 HR

Omeprazole

Delayed Release- Capsules

20 mg*

ACID REDUCER

14 Capsules(Safety Sealed)

One 14-Day Course of Treatment

May take 1 to 4 days for full effect

Other 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 Ingredients (Inactive ingredients)

black iron oxide, dibasic calcium phosphate, gelatin, glyceryl monostearate, hypromellose 3 cps, magnesium oxide, magnesium stearate, methacrylic acid copolymer dispersion, methacrylic acid copolymer Type B, microcrystalline cellulose, polysorbate 80, potassium hydroxide, propylene glycol, red iron oxide, shellac, silicon dioxide, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate

Do Not Use If You Have: (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.

Stop Use and Ask Doctor If: (Stop use and ask 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

 

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

Revised: 10/2022

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

*Omeprazole delayed-release capsules 20 mg (equivalent to 20.6 mg omeprazole magnesium)

Ask A Doctor Before Use If You Have: (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

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking a prescription drug.

Acid reducers may interact with certain prescription drugs.


Advanced Ingredient Data


Raw Label Data

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