Prescription Drug Information: Prilosec (Page 10 of 10)

INSTRUCTIONS FOR USE

PRILOSEC ® (pry-lo-sec) (omeprazole magnesium)for delayed-release oral suspension

Taking PRILOSEC in water:

1.
PRILOSEC comes in packets containing 2.5 mg and 10 mg of PRILOSEC.
2.
Use an oral syringe to draw up the amount of water needed to mix your dose. Ask your pharmacist for an oral syringe.
3.
If your dose of PRILOSEC is 2.5 mg, add 5 mL of water to a clean container. Empty the contents of the 2.5 mg packet into the container of water.
4.
If your dose of PRILOSEC is 10 mg, add 15 mL of water to a clean container. Empty the contents of the 10 mg packet into the container of water.
5.
If you or your child are instructed to use more than 1 packet for your dose of PRILOSEC, follow the mixing instructions provided by your pharmacist or doctor.
6.
Stir.
7.
Leave the mixture for 2 to 3 minutes to thicken.
8.
Stir and drink the mixture within 30 minutes. If not used within 30 minutes, throw away this dose and mix a new dose.
9.
If any medicine remains after drinking, add more water, stir, and drink right away.

Giving PRILOSEC with water through a nasogastric (NG) tube or gastric tube:

For people who have an NG tube or gastric tube that is size 6 or larger , PRILOSEC may be given as follows:

1.
PRILOSEC comes in packets containing 2.5 mg and 10 mg of PRILOSEC.
2.
Use only a catheter tipped syringe to give PRILOSEC through an NG tube or gastric tube that is size 6 or larger.
3.
If your dose of PRILOSEC is 2.5 mg, add 5 mL of water to a catheter tipped syringe. Add the contents of the 2.5 mg packet to the syringe.
4.
If your dose of PRILOSEC is 10 mg, add 15 mL of water to a catheter tipped syringe. Add the contents of the 10 mg packet to the syringe.
5.
Shake the syringe right away and then leave the mixture for 2 to 3 minutes to thicken.
6.
Shake the syringe and inject through the NG tube or gastric tube into the stomach within 30 minutes.
7.
Refill the syringe with the same amount of water you used to prepare your dose of PRILOSEC (5 mL or 15 mL of water depending on your dose).

Shake the syringe and flush any remaining medicine from the NG tube or gastric tube into the stomach.

PRINCIPAL DISPLAY PANEL — 2.5 mg Carton Label

Principal Display Panel -- 2.5 mg Carton Label
(click image for full-size original)

2.5 mg Carton Label

NDC 70515-625-01

30 Single Dose
Packets

PRILOSEC®
(OMEPRAZOLE MAGNESIUM*)
FOR DELAYED-RELEASE
ORAL SUSPENSION

2.5 mg

Each carton contains 30 child-resistant packets.

*Each packet contains:
Omeprazole . . . . . . . . . 2.5 mg
(equivalent to 2.8 mg of omeprazole magnesium trihydrate)

Dispense the enclosed Medication Guide to each patient.

Rx only

COVIS

NDC 70515-625-01

PRILOSEC®
(OMEPRAZOLE MAGNESIUM*)
FOR DELAYED-RELEASE
ORAL SUSPENSION

2.5 mg

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature].
USUAL ADULT DOSAGE: See package insert.
PRILOSEC For Delayed-Release Oral Suspension should be administered as follows:
• Empty the contents of a 2.5 mg packet into a container containing 1 teaspoon (5 mL) of water
• Stir
• Leave 2 to 3 minutes to thicken
• Stir and drink within 30 minutes
• If any material remains after drinking, add more water, stir, and drink immediately

© Covis Pharma 2018
Manufactured for: Covis Pharma, Zug, 6300 Switzerland
Made in France

GTIN XXXXXXXXXXXXXX
LOT XXXXXXX
EXP MM-YYYYSN XXXXXXXXXXXXXXXXXXXX

PRINCIPAL DISPLAY PANEL — 10 mg Carton Label

Principal Display Panel -- 10 mg Carton Label
(click image for full-size original)

10 mg Carton Label

NDC 70515-610-01

30 Single Dose
Packets

PRILOSEC®
(OMEPRAZOLE MAGNESIUM*)
FOR DELAYED-RELEASE
ORAL SUSPENSION

10 mg

Each carton contains 30 child-resistant packets.

*Each packet contains:
Omeprazole . . . . . . . . . 10 mg
(equivalent to 11.2 mg of omeprazole magnesium trihydrate)

Dispense the enclosed Medication Guide to each patient.

Rx only

COVIS

NDC 70515-610-01

PRILOSEC®
(OMEPRAZOLE MAGNESIUM*)
FOR DELAYED-RELEASE
ORAL SUSPENSION

10 mg

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature].
USUAL ADULT DOSAGE: See package insert.

PRILOSEC For Delayed-Release Oral Suspension should be administered as follows:
• Empty the contents of a 10 mg packet into a container containing 1 tablespoon (15 mL) of water
• Stir
• Leave 2 to 3 minutes to thicken
• Stir and drink within 30 minutes
• If any material remains after drinking, add more water, stir, and drink immediately

© Covis Pharma 2018
Manufactured for: Covis Pharma, Zug, 6300 Switzerland
Made in France

GTIN XXXXXXXXXXXXXX
LOT XXXXXXX
EXP MM-YYYYSN XXXXXXXXXXXXXXXXXXXX

PRILOSEC omeprazole magnesium granule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70515-625
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEPRAZOLE MAGNESIUM (OMEPRAZOLE) OMEPRAZOLE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
GLYCERYL MONOSTEARATE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
POLYSORBATE 80
TALC
TRIETHYL CITRATE
XANTHAN GUM
CITRIC ACID MONOHYDRATE
DEXTROSE, UNSPECIFIED FORM
CROSPOVIDONE, UNSPECIFIED
FERRIC OXIDE RED
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70515-625-01 30 GRANULE, DELAYED RELEASE in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022056 08/25/2017
PRILOSEC omeprazole magnesium granule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70515-610
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEPRAZOLE MAGNESIUM (OMEPRAZOLE) OMEPRAZOLE 10 mg
Inactive Ingredients
Ingredient Name Strength
GLYCERYL MONOSTEARATE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
POLYSORBATE 80
TALC
TRIETHYL CITRATE
XANTHAN GUM
CITRIC ACID MONOHYDRATE
DEXTROSE, UNSPECIFIED FORM
CROSPOVIDONE, UNSPECIFIED
FERRIC OXIDE RED
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70515-610-01 30 GRANULE, DELAYED RELEASE in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022056 08/25/2017
Labeler — Covis Pharma (486209070)

Revised: 11/2019 Covis Pharma

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