CAREONE ACID REDUCER- famotidine tablet, film coated 
American Sales Company

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American Sales Company Acid Relief Drug Facts

Active ingredient (in each tablet)

Famotidine 10 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

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

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

Inactive ingredients

carnauba wax, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, talc, titanium dioxide, triacetin

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredient in Pepcid® AC

ORIGINAL STRENGTH

ACID RELIEF

Famotidine Tablets, 10 mg

Acid Reducer

Just one tablet prevents & relieves heartburn due to acid indigestion

See New Warnings

Gluten Free

OUR PHARMACISTS RECOMMEND

Actual Size

30 TABLETS

Acid Relief Carton Image 1
Acid Relief Carton Image 2
CAREONE ACID REDUCER 
famotidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-901
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE10 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize8mm
FlavorImprint Code L141
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-901-721 in 1 CARTON10/04/2016
160 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:41520-901-6530 in 1 CARTON10/04/2016
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07540010/04/2016
Labeler - American Sales Company (809183973)

Revised: 10/2023
Document Id: 6e86c968-a2ed-49c7-bb6a-2777627444f1
Set id: ed474c9d-c08b-4f52-8b24-5887978e4275
Version: 6
Effective Time: 20231020
 
American Sales Company