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 20mg

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

• 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 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 n 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
• store at 20°-25°C (68°-77°F)
• protect from moisture

Inactive ingredients

Hydroxypropyl cellulose, hypromellose, macrogol, magnesium stearate, microcrystalline
cellulose, pre-gelatinized starch, sodium starch glycolate, talc, titanium dioxide, triacetin

Questions/Comments

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

Principal Display Panel

Famotidine Tablets, 20mg

INGREDIENTS AND APPEARANCE

ACID REDUCER  MAXIMUM STRENGTH
famotodine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69168-443
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
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	V;15
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69168-443-32	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/15/2024
2	NDC: 69168-443-52	225 in 1 BOTTLE; Type 0: Not a Combination Product	01/15/2024
3	NDC: 69168-443-09	10 in 1 BLISTER PACK; Type 0: Not a Combination Product	02/29/2024
4	NDC: 69168-443-50	1 in 1 CARTON	03/05/2024
4		50 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 69168-443-99	365 in 1 BOTTLE; Type 0: Not a Combination Product	10/28/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA215822	01/15/2024

Labeler - Allegiant Health (079501930)