SUNMARK OMEPRAZOLE- omeprazole tablet, delayed release

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

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Active ingredient:
OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9)
Available from:
Strategic Sourcing Services LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Acid reducer
Authorization status:
New Drug Application
Authorization number:
49348-846-46, 49348-846-55, 49348-846-61, 49348-846-78

SUNMARK OMEPRAZOLE- omeprazole tablet, delayed release

Strategic Sourcing Services LLC

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McKesson Omeprazole Delayed Release Tablets 20 mg 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 pain 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

you need to take more than 1 course of treatment every 4 months

you get diarrhea

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

Other information

Inactive ingredients

carnauba wax, ferric oxide red, ferric oxide yellow, hypromellose, hypromellose acetate succinate,

lactose monohydrate, monoethanolamine, propylene glycol, sodium lauryl sulfate, sodium starch

glycolate, sodium stearate, sodium stearyl fumarate, talc, titanium dioxide, triethyl citrate

Questions or comments?

1-800-719-9260

Principal Display Panel

COMPARE TO Prilosec OTC

See Current Drug Facts

omeprazole

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

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.

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

Delayed Release Tablets 20 mg

Acid Reducer

TREATS FREQUENT HEARTBURN!

Actual Size

24 HR

14 TABLETS

One 14-day course of treatment

May take 1 to 4 days for full effect

SUNMARK OMEPRAZOLE

omeprazole tablet, delayed release

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:49 348 -8 46

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

CARNAUBA WAX (UNII: R12CBM0 EIZ)

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

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

MO NO ETHANO LAMINE (UNII: 5KV8 6 114PT)

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

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

SO DIUM STEARATE (UNII: QU7E2XA9 TG)

SO DIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

TRIETHYL CITRATE (UNII: 8 Z9 6 QXD6 UM)

Product Characteristics

Color

BROWN

S core

no sco re

S hap e

OVAL

S iz e

12mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:49 348 -8 46 -46

14 in 1 CARTON

0 2/26 /20 0 8

1

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

Strategic Sourcing Services LLC

2

NDC:49 348 -8 46 -78

28 in 1 CARTON

0 2/26 /20 0 8

2

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

3

NDC:49 348 -8 46 -6 1 42 in 1 CARTON

0 2/26 /20 0 8

3

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

4

NDC:49 348 -8 46 -55

1 in 1 CARTON

11/16 /20 10

0 8 /0 1/20 13

4

14 in 1 BOTTLE; 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

NDA0 220 32

0 2/26 /20 0 8

Labeler -

Strategic Sourcing Services LLC (116956644)

Revised: 9/2019

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