Omeprazole by Reliable 1 Laboratories LLC OMEPRAZOLE capsule

Omeprazole by

Drug Labeling and Warnings

Omeprazole by is a Otc medication manufactured, distributed, or labeled by Reliable 1 Laboratories LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each capsule)

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

Purpose

Acid reducer

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

Warnings

Allergy alert: Do not use if you are allergic to omeprazole

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 DOCTOR

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 DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking:

• warfarin, clopidogrel or cilostazol (blood-thinning medicines)
• prescription antifungal or anti-yeast medicines
• diazepam (anxiety medicine)
• digoxin (heart medicine)
• tacrolimus or mycophenolate mofetil (immune system medicines)
• prescription antiretrovirals (medicines for HIV infection)
• methotrexate (arthritis medicine)

STOP USE

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

PREGNANCY OR BREAST FEEDING

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

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.

Directions

• for adults 18 years of age and older
• this prodcut 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 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 serious condition.

Other information

• read the directions and warnings before use
• keep the carton. It contains important information.
• store at 20-25ºC (68-77ºF) and protect from moisture

Inactive ingredients

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

Questions?

call 1-888-375-3784

PRINCIPAL DISPLAY PANEL

NDC: 69618-047-42

Compare to the active ingredient in Prilosec OTC®** Treats Frequent Heartburn!

Omeprazole

Delayed-release Capsules

20 mg*

Acid Reducer

24HR

42 Capsules (Safety Sealed)

Three 14-Day Courses of Treatment

May take 1 to 4 days for full effect

INGREDIENTS AND APPEARANCE

OMEPRAZOLE 
omeprazole capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69618-047
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
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
RAW SUGAR (UNII: 8M707QY5GH)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CARRAGEENAN (UNII: 5C69YCD2YJ)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SHELLAC (UNII: 46N107B71O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TALC (UNII: 7SEV7J4R1U)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2) (UNII: 5KY68S2577)
HYPROMELLOSE 2208 (3 MPA.S) (UNII: 9H4L916OBU)

Product Characteristics
Color	pink (Half White, Half Pink) , white (Half White, Half Pink)	Score	no score
Shape	CAPSULE	Size	22mm
Flavor		Imprint Code	OMP20
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69618-047-42	3 in 1 CARTON	08/16/2018
1	NDC: 69618-047-14	14 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078878	08/16/2018

Labeler - Reliable 1 Laboratories LLC (079718111)