Famotidine 10 mg and 20 mg Tablets (OTC)

Acid Controller by

Drug Labeling and Warnings

Acid Controller by is a Otc medication manufactured, distributed, or labeled by CVS Health Corp, Dr. Reddy's Laboratories Louisiana LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

  • relieves heartburn associated with acid indigestion and sour stomach
  • prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages

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

  • For Famotidine 10 mg:
  • adults and children 12 years and over:
    • to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
    • to prevent symptoms, swallow 1 tablet with a glass of water at any time from 15 to 60 minutes before eating food or drinking beverages that cause heartburn
    • do not use more than 2 tablets in 24 hours
  • children under 12 years: ask a doctor
  • For Famotidine 20 mg:
  • adults and children 12 years and over:
    • to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
    • to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn
    • do not use more than 2 tablets in 24 hours
  • children under 12 years: ask a doctor

Other information

  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20°-25°C (68°-77°F)
  • protect from moisture and light

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

  • Do not lie flat or bend over after eating
  • Do not wear tight-fitting clothing around the stomach
  • Do not eat before bedtime
  • Raise the head of your bed
  • Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol and certain fruits and vegetables
  • Eat slowly and avoid big meals
  • If overweight, lose weight
  • Quit smoking

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION

10mgcarton

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION

20mgcarton

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
ColorPINKScoreno score
ShapeROUNDSize6mm
FlavorImprint Code C;118
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69842-266-401 in 1 CARTON10/01/202010/31/2023
140 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC: 69842-266-901 in 1 CARTON10/01/202010/31/2023
290 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC: 69842-266-301 in 1 CARTON12/01/202010/31/2023
330 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07736710/01/202010/31/2023
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 CARTON10/01/202009/30/2023
165 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC: 69842-267-131 in 1 CARTON10/01/202009/30/2023
2130 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC: 69842-267-501 in 1 CARTON12/01/202009/30/2023
350 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC: 69842-267-101 in 1 CARTON12/01/202009/30/2023
4100 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC: 69842-267-251 in 1 CARTON12/15/202009/30/2023
525 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07736710/01/202009/30/2023
Labeler - CVS Health Corp (062312574)
Establishment
NameAddressID/FEIBusiness Operations
Dr. Reddy's Laboratories Louisiana LLC830397282analysis(69842-266, 69842-267)

Revised: 7/2025
Document Id: 2950256d-9973-aae8-1966-2fe0f5dbca30
Set id: 111a0385-0d44-d50e-28a6-54322138536b
Version: 10
Effective Time: 20250717
 
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