ESOMEPRAZOLE MAGNESIUM - esomeprazole magnesium capsule, delayed release 
Camber Consumer Care Inc

----------

Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg (OTC)

ACTIVE INGREDIENT (in each capsule)

Esomeprazole 20 mg
(*Each delayed-release capsule corresponds to 22.25 mg esomeprazole magnesium trihydrate USP).

PURPOSE

Acid reducer

USES

WARNINGS

Allergy alert:

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




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 right away.

DIRECTIONS

• adults 18 years of age and older
• this product is to be used once a day (every 24 hours), every day for 14 days
• may 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 for more than 14 days unless directed by your doctor

   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 before use. Heartburn in children may sometimes be caused by a serious condition.

OTHER INFORMATION

INACTIVE INGREDIENTS

Black iron oxide, FD&C Blue No. 1, FD&C Blue No. 2, gelatin, glyceryl monostearate, hydroxy propyl cellulose, hypromellose, magnesium stearate, methacrylic acid ethyl acrylate copolymer, potassium hydroxide, polysorbate 80, propylene glycol, shellac, simethicone, sodium lauryl sulfate, strong ammonia solution, sugar spheres (contains sucrose and corn starch), talc, titanium dioxide, triethyl citrate.

QUESTIONS OR COMMENTS?

call toll-free weekdays 9 AM to 5 PM EST at 1-888-588-1418.


Distributed by:
Camber Consumer Care, Inc.

Piscataway, NJ 08854, USA.

PRINCIPAL DISPLAY PANEL

Esomeprazole Magnesium Delayed-Release Capsules, USP, 20 mg - Carton


cartonlabel
ESOMEPRAZOLE MAGNESIUM  
esomeprazole magnesium capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69230-320
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE20 mg
Inactive Ingredients
Ingredient NameStrength
TALC (UNII: 7SEV7J4R1U)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
GELATIN (UNII: 2G86QN327L)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: MB5IUD6JUA)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SUCROSE (UNII: C151H8M554)  
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
AMMONIA (UNII: 5138Q19F1X)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
Product Characteristics
Colorwhite (white opaque cap) , blue (blue opaque body) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint Code H;E4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69230-320-311 in 1 CARTON06/02/2020
114 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:69230-320-322 in 1 CARTON06/02/2020
214 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:69230-320-333 in 1 CARTON06/02/2020
314 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21250706/02/2020
Labeler - Camber Consumer Care Inc (079539968)
Establishment
NameAddressID/FEIBusiness Operations
Hetero Labs Limited Unit III676162024manufacture(69230-320)

Revised: 1/2023
Document Id: f314566e-27c9-2871-e053-2995a90a7850
Set id: d2554c3d-eb0b-4bf8-aebc-18be7b195c8e
Version: 4
Effective Time: 20230125
 
Camber Consumer Care Inc