ESOMEPRAZOLE MAGNESIUM- esomeprazole magnesium capsule, delayed release 
TIME CAP LABORATORIES, INC.

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49483-718 Esomeprazole magnesium delayed release capsules USP, 20mg

Drug Facts

Active ingredient (in each capsule)

Esomeprazole 20 mg

(Each delayed-release capsule corresponds to 22.3 mg

esomeprazole magnesium trihydrate)

Purpose

Acid reducer

Uses

Warnings

Allergy alert

-skin reddening
-blisters
-rash

If an allergic reaction occurs, stop use and seek medical attention 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

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

  1. swallow 1 capsule with a glass of water before eating in the morning
  2. take every day for 14 days
  3. do not take more than 1 capsule a day
  4. swallow whole. Do not crush or chew capsules.
  5. do not use for more than 14 days unless directed by your doctor

Repeated 14-Day Courses (if needed)

  1. you may repeat a 14-day course every 4 months
  2. do not take for more than 14 days or more often than every 4 months unless directed by a doctor

Other information

Inactive ingredientsblack iron oxide, eudragit, FD&C blue 1, FD&C red 3, ferric oxide yellow, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, polysorbate 80, potassium hydroxide, shellac, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate.

Questions or comments?Call 1-877-290-4008

718T-Esomeprazole-42ct-carton718T-Esomeprazole-14ct-label

ESOMEPRAZOLE MAGNESIUM 
esomeprazole magnesium capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-718
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE20 mg
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SHELLAC (UNII: 46N107B71O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
Colorpurple (PURPLE (golden cap and violet transparent body having light violet to violet colour band)) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint Code 75
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49483-718-413 in 1 CARTON11/14/2023
114 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21726411/14/2023
Labeler - TIME CAP LABORATORIES, INC. (037052099)
Registrant - TIME CAP LABORATORIES, INC. (037052099)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LIMITED925822975manufacture(49483-718)

Revised: 11/2023
Document Id: 08ad180e-e87a-ba6f-e063-6394a90a2bc7
Set id: 08acf79f-f50d-8416-e063-6294a90a2704
Version: 1
Effective Time: 20231123
 
TIME CAP LABORATORIES, INC.