ACID CONTROLLER  ORIGINAL STRENGTH- famotidine tablet 
ACID CONTROLLER  MAXIMUM STRENGTH- famotidine tablet 
CVS Health Corp

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Famotidine 10 mg and 20 mg Tablets (OTC)

Active ingredient (in each tablet)

Famotidine USP, 10 mg/20 mg

Purpose

Acid reducer

Uses

Warnings

Allergy alert: Do not use if you are allergic to famotidine or other acid reducers

Do not use

  • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
  • with other acid reducers

Ask a doctor before use if you have

  • had heartburn over 3 months. This may be a sign of a more serious condition.
  • 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
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain
  • kidney disease

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

  • your heartburn continues or worsens
  • you need to take this product for more than 14 days

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

colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, synthetic red iron oxide (only in 10 mg), talc and titanium dioxide

Questions or comments?

call 1-888-375-3784

Tips For Managing Heartburn

Tips for Managing Heartburn

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION

10 mg carton

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION

20 mg carton

ACID CONTROLLER   ORIGINAL STRENGTH
famotidine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-266(NDC:55111-118)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE10 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
STARCH, CORN (UNII: O8232NY3SJ)  
Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize6mm
FlavorImprint Code C;118
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-266-401 in 1 CARTON10/01/2020
140 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:69842-266-901 in 1 CARTON10/01/2020
290 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:69842-266-301 in 1 CARTON12/01/2020
330 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07736710/01/2020
ACID CONTROLLER   MAXIMUM STRENGTH
famotidine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-267(NDC:55111-396)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE20 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
STARCH, CORN (UNII: O8232NY3SJ)  
Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize8mm
FlavorImprint Code L1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-267-651 in 1 CARTON10/01/2020
165 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:69842-267-131 in 1 CARTON10/01/2020
2130 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:69842-267-501 in 1 CARTON12/01/2020
350 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:69842-267-101 in 1 CARTON12/01/2020
4100 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:69842-267-251 in 1 CARTON12/15/2020
525 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07736710/01/2020
Labeler - CVS Health Corp (062312574)
Establishment
NameAddressID/FEIBusiness Operations
Dr. Reddy's Laboratories Louisiana LLC830397282analysis(69842-266, 69842-267)

Revised: 9/2020
Document Id: 424ccee0-e732-7187-d4d6-dfdd3874096d
Set id: 111a0385-0d44-d50e-28a6-54322138536b
Version: 5
Effective Time: 20200904
 
CVS Health Corp