ACID REDUCER MAXIMUM STRENGTH- famotodine tablet

Acid Reducer by

Drug Labeling and Warnings

Acid Reducer by is a Otc medication manufactured, distributed, or labeled by Allegiant Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(s)

Famotidine USP 20 mg

Purpose

Acid reducer

Use(s)

• 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 
• explained 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 breastfeeding,

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 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
• do not use if imprinted safety seal under cap is broken or
  missing n store at 20°-25°C (68°-77°F)
• protect from moisture

Inactive ingredients

carnauba wax, corn starch, hydroxypropyl cellulose,
hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline
cellulose, sodium starch glycolate, talc, titanium dioxide

Questions/Comments

Call 1-888-952-0050 Monday through Friday
9AM − 5PM EST

Principal Display Panel

Acid Reducer

INGREDIENTS AND APPEARANCE

ACID REDUCER  MAXIMUM STRENGTH
famotodine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69168-445
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8)	FAMOTIDINE	20 mg

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
STARCH, CORN (UNII: O8232NY3SJ)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	T;11
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69168-445-32	100 in 1 BOTTLE; Type 0: Not a Combination Product	10/31/2024
2	NDC: 69168-445-52	225 in 1 BOTTLE; Type 0: Not a Combination Product	10/31/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA215767	10/31/2024

Labeler - Allegiant Health (079501930)