OMEPRAZOLE- omeprazole tablet, orally disintegrating, delayed release

United States - English - NLM (National Library of Medicine)

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Active ingredient:
OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9)
Available from:
Walgreen Company
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Acid reducer These may be signs of a serious condition. See your doctor. taking a prescription drug. Acid reducers may interact with certain prescription drugs.
Authorization status:
New Drug Application
Authorization number:
0363-1819-55, 0363-1819-74

OMEPRAZOLE- omeprazole tablet, orally disintegrating, delayed release

Walgreen Company

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Walgreen Co. Omeprazole Drug Facts

Active ingredient (in each tablet)

Omeprazole 20 mg

Purpos e

Acid reducer

Us e

Warnings

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

Do not use if you have:

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

taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Stop use and ask a doctor if:

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

trouble or pain swallowing food, vomiting with blood, or bloody or black stools

heartburn with lightheadedness, sweating or dizziness

chest or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or

shoulders; or lightheadedness

frequent chest pain

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

your heartburn continues or worsens

you need to take this product for more than 14 days

If pregnant or breast-feeding,

ask a health professional before use.

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).

Directions

14-Day Course of Treatment

Repeated 14-Day Course (if needed)

Other information

Inactive ingredients

amino methacrylate copolymer, ascorbic acid, cetyl alcohol, colloidal silicon dioxide, crospovidone,

ferric oxide, flavor, hypromellose, hypromellose phthalate, maize maltodextrin, mannitol,

microcrystalline cellulose, propylene glycol, silicon dioxide, sodium stearate, sodium stearyl fumarate,

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

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

take 1 tablet before eating in the morning

do not crush or chew tablets

place the tablet on tongue; tablet disintegrates, with or without water. The tablets can also be

swallowed whole with water.

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

do not take this medicine with alcohol

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 before use. Heartburn in children may sometimes be

caused by a serious condition.

read the directions and warnings before use

keep the carton. It contains important information.

store at 20-25°C (68-77°F); keep product out of high heat and moisture

sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate

Questions or comments?

1-800-719-9260: weekdays 7:30 AM to 5:00 PM EST

Package/Label Principal Display Panel

MELTech™

Melts In Your Mouth

Compare to Prilosec OTC®

Omeprazole

DELAYED RELEASE ORALLY DISINTEGRATING TABLETS 20 mg

ACID REDUCER

MELTS IN YOUR MOUTH; DISSOLVES WITHOUT WATER

ORALLY DISINTEGRATING TABLETS

24 HR

Treats frequent heartburn!

ACTUAL SIZE

42 TABLETS

THREE 14-DAY COURSES OF TREATMENT

MAY TAKE 1 TO 4 DAYS FOR FULL EFFECT

STRAWBERRY FLAVOR

OMEPRAZOLE

omeprazole tablet, orally disintegrating, delayed release

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 36 3-18 19

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O MEPRAZO LE (UNII: KG6 0 48 4QX9 ) (OMEPRAZOLE - UNII:KG6 0 48 4QX9 )

OMEPRAZOLE

20 mg

Inactive Ingredients

Ingredient Name

Stre ng th

DIMETHYLAMINO ETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE

CO PO LYMER (UNII: 9 0 5HNO1SIH)

ASCO RBIC ACID (UNII: PQ6 CK8 PD0 R)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CRO SPO VIDO NE ( 15 MPA.S AT 5%) (UNII: 6 8 40 19 6 0 MK)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

Walgreen Company

MANNITO L (UNII: 3OWL53L36 A)

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

SO DIUM STEARATE (UNII: QU7E2XA9 TG)

SO DIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)

SO RBITO L (UNII: 50 6 T6 0 A25R)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

TRIETHYL CITRATE (UNII: 8 Z9 6 QXD6 UM)

Product Characteristics

Color

RED (reddish)

S core

no sco re

S hap e

ROUND

S iz e

9 mm

Flavor

STRAWBERRY

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 36 3-18 19 -55

3 in 1 CARTON

0 3/0 1/20 18

1

14 in 1 CARTON

1

1 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:0 36 3-18 19 -74

14 in 1 CARTON

0 3/0 6 /20 18

2

1 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA20 9 40 0

0 3/0 1/20 18

Labeler -

Walgreen Company (008965063)

Revised: 4/2019

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