AMAZON BASIC CARE OMEPRAZOLE - omeprazole tablet, delayed release 
Amazon.com Services LLC

----------

Tips for Managing Heartburn

Drug Facts

Active ingredient (in each tablet)

Omeprazole delayed-release tablet 20 mg (equivalent to 20.6 mg omeprazole magnesium USP)

Purpose

Acid reducer

Use

Warnings

Allergy alert:

•  Do not use if you are allergic to omeprazole.
•  Omeprazole may cause severe skin reactions. Symptoms may include:
      •  skin reddening   •  blisters   •  rash

If an allergic reaction occurs, stop use and seek medical help right away.

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:

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 (1-800-222-1222)  right away.

Directions

  14-Day Course of Treatment

  Do not chew or crush tablets.

  Repeated 14-Day Courses (if needed)

Other information

Inactive ingredients

crospovidone, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, polyethylene glycol, polysorbate 80, red iron oxide, silicified microcrystalline cellulose, sodium hydroxide, sodium stearyl fumarate, sugar spheres [which contains liquid glucose, starch (maize) and sucrose], talc, titanium dioxide, triethyl citrate and yellow iron oxide.

Questions?

Call 1-855-274-4122

DISTRIBUTED BY:
AMAZON.COM SERVICES LLC
410 TERRY AVENUE N.
SEATTLE, WA 98109

Made in India



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablet Bottle)

amazon
basic+care

See current Drug Facts    NDC 72288-409-05

Omeprazole
Delayed-Release Tablets 20 mg

Acid Reducer

Treats Frequent                                              14 TABLETS
Heartburn!                        One 14-day course of treatment
24 HR                           May take 1 to 4 days for full effect


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablet Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg Container Carton Label

amazon
basic+care

Acid Reducer

Compare to
Prilosec OTC®
    active
ingredient*

NDC 72288-409-05

See current Drug Facts
Omeprazole
Delayed-Release Tablets
20 mg

Acid Reducer

Treats Frequent Heartburn!      
24 HR

actual size

14 TABLETS
One 14-day course of treatment
May take 1 to 4 days for full effect
 
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg Container Carton Label

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg Blister Carton Label

amazon
basic+care

Acid Reducer    NDC 72288-409-01

Compare to
Prilosec OTC®
     active
ingredient*

See current Drug Facts
Omeprazole
Delayed-Release Tablets 20 mg

Acid Reducer

Treats Frequent Heartburn!      
24 HR
actual size                            One 14-day course of treatment
                                            May take 1 to 4 days for full effect
  

14 (1 x 14) TABLETS

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg Blister Carton Label

AMAZON BASIC CARE OMEPRAZOLE 
omeprazole tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72288-409
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE MAGNESIUM (UNII: 426QFE7XLK) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE (35 .MU.M) (UNII: 40UAA97IT9)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F)  
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
STARCH, CORN (UNII: O8232NY3SJ)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYDROXYPROPYL CELLULOSE (45000 WAMW) (UNII: 8VAB711C5E)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
Product Characteristics
ColorPINKScoreno score
ShapeRECTANGLE (Oblong) Size14mm
FlavorImprint Code Z;69
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72288-409-051 in 1 CARTON05/15/2024
114 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:72288-409-011 in 1 CARTON05/15/2024
214 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:72288-409-612 in 1 CARTON05/15/2024
314 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:72288-409-033 in 1 CARTON05/15/2024
414 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20687705/15/2024
Labeler - Amazon.com Services LLC (128990418)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(72288-409) , MANUFACTURE(72288-409)

Revised: 5/2024
Document Id: 0e2645ca-76b7-4f38-9513-cba86dfa20a3
Set id: 10efef7c-bdf4-36cf-e063-6394a90a8c0f
Version: 2
Effective Time: 20240510
 
Amazon.com Services LLC