Esomeprazole by Reliable 1 Laboratories ESOMEPRAZOLE capsule

Esomeprazole by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active ingredient (in each capsule)

*Esomeprazole 20 mg (Each delayed-release capsule corresponds to 20.7 mg esomeprazole magnesium, USP)

Purpose

Acid reducer

Uses

treats frequent heartburn (occurs 2 or more days a week)

not intended for innediate 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 esomeprazole

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 sings 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, particulary 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, clopifogrel or cilostazol (blood-thinning medicines)

prescription antifungal or anti-yeast medications

digozin (heart medicine)

diazepam (anxiety medicine)

tacrolimus or mycophenolate mofetil (immune system medicines)

prescription antiretovirals (medicines for HIV infections)

methotrexate (arthritis medicine)

STOP USE

Stop use and ask a doctor if

your heartburn continues or worsens

you need to take this prodcut 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 prefessional before use

KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contract a Posion Control Center right away.

Directions

adults 18 years of age and older

this prodcut is to be used once a day (every 24 hours), every day for 14 days

make take 1 to 4 days for full effect

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

swallow whole. Do not crush or chew capsules.

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

Repeated 14-Day Courses (if needed)

you may repeart a 14-day course every 4 months

do not take for more than 14 days or more often than every 4 mounths unless directed by a doctor

children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be cuased by a serious condition.

Other Information

each capsule contains: magnesium, 15 mg

read the directions and warmings before use

keep the carton. It contains important information.

store at 20-25ºC (68 to 77ºF)

Inactive ingredients

acetyl tributyl citrate, dibutyl sebacate, FD&C Blue #1, ferroso ferric oxide, gelatin, glyceryl monostearate, hypromellose, magnesium odixe, magnesium stearate, methacrylic acid copolymer dispersion, poloxamer, polysorbate 80, povidone, potassium hydroxide, propylene glycol, shellac, sugar, talc, titanium dioxide

Questions or comments?

call tool-free weekdays 8 AM to 10 PM EST at 1-888-375-3784

PRINCIPAL DISPLAY PANEL

NDC: 69618-056-42

Compare to the active ingredient in Nexium® 24 HR**

Esomeprazole Magnesium

Delayed-Release Capsules, USP

20 mg*

Acid Reducer

42 Capsules

Three 14-day Courses of Treatment

INGREDIENTS AND APPEARANCE

ESOMEPRAZOLE 
esomeprazole capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69618-056
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT)	ESOMEPRAZOLE	20 mg

Inactive Ingredients
Ingredient Name	Strength
GELATIN (UNII: 2G86QN327L)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE (UNII: FZ989GH94E)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
SHELLAC (UNII: 46N107B71O)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
DIBUTYL SEBACATE (UNII: 4W5IH7FLNY)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLOXAMER 188 (UNII: LQA7B6G8JG)
ACETYLTRIBUTYL CITRATE (UNII: 0ZBX0N59RZ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	yellow (Gelatin capsule shell with light blue cap and dark blue body)	Score	no score
Shape	OVAL (Capsule)	Size	9mm
Flavor		Imprint Code	RDY;327
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69618-056-42	3 in 1 CARTON	11/01/2018
1	NDC: 69618-056-14	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	ANDA207673	11/01/2018

Labeler - Reliable 1 Laboratories (079718111)