445 - Acid Reducer - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Famotidine (20 mg)

Inactive Ingredients

Carnauba Wax Starch, Corn Hydroxypropyl Cellulose, Unspecified Hypromellose, Unspecified Ferric Oxide Red Ferric Oxide Yellow Magnesium Stearate

Identifiers & Packaging

Pill Appearance

Imprint: T;11 Shape: round Color: yellow Size: 6 mm Score: 1

Marketing Status

ANDA Active Since 2024-10-31

Medication Information

Purpose

Acid reducer

Description

Famotidine USP 20 mg

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

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

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

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

Questions/comments

Call 1-888-952-0050 Monday through Friday

9AM − 5PM EST

Active Ingredient(s)

Famotidine USP 20 mg

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

Principal Display Panel

Acid Reducer

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

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)

Ask A Doctor Or Pharmacist Before Use If

you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Structured Label Content

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

Purpose

Acid reducer

Warnings

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

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

Do Not Use (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

Other Information (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

Questions/comments (Questions/Comments)

Call 1-888-952-0050 Monday through Friday

9AM − 5PM EST

Active Ingredient(s) (Active ingredient(s))

Famotidine USP 20 mg

Inactive Ingredients (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

Principal Display Panel

Acid Reducer

Ask A Doctor Before Use If (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

Stop Use and Ask A Doctor If (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, (If pregnant or breastfeeding,)

ask a health professional before use.

Keep Out of Reach of Children (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)

Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)

you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Advanced Ingredient Data

[{"name": "FAMOTIDINE", "unii": "5QZO15J2Z8", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CARNAUBA WAX", "unii": "R12CBM0EIZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYPROPYL CELLULOSE, UNSPECIFIED", "unii": "9XZ8H6N6OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE RED", "unii": "1K09F3G675", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE YELLOW", "unii": "EX438O2MRT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "Purpose": "Acid reducer", "Warnings": "Allergy alert: Do not use if you are allergic to famotidine or other acid reducers", "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", "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", "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", "Questions/Comments": "Call 1-888-952-0050 Monday through Friday 9AM − 5PM EST", "Active ingredient(s)": "Famotidine USP 20 mg", "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", "Principal Display Panel": "Acid Reducer", "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", "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)", "Ask a doctor or pharmacist before use if": "you are taking a prescription drug. Acid reducers may interact with certain prescription drugs."}

445 - Acid Reducer

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information