Famotidine Tablet, Film Coated

Famotidine Tablet, Film Coated
SPL v3
SPL
SPL Set ID befd8d44-c6f7-eca2-e053-2995a90a714b
Route
ORAL
Published
Effective Date 2021-04-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Famotidine (10 mg)
Inactive Ingredients
Magnesium Stearate Starch, Corn Hydroxypropyl Cellulose (1600000 Wamw) Carnauba Wax Hypromellose 2910 (5 Mpa.s) Talc Sodium Starch Glycolate Type A Corn Microcrystalline Cellulose Ferric Oxide Red Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: CC;58 Shape: round Color: pink Size: 5 mm Score: 1
Marketing Status
ANDA Active Since 2021-04-07

Description

Drug Facts

Purpose

Acid reducer


Medication Information

Purpose

Acid reducer

Description

Drug Facts

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
Section 42229-5

Drug Facts

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 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
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
  • keep the carton. It contains important information.
  • store at 20° to 25°C (68° to 77°F)
  • protect from moisture
Inactive Ingredients

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

Questions Or Comments?

call 1-855-274-4122

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

JUST ONE TABLET prevents and relieves heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages.







Do not use if carton is open or if printed foil seal under bottle cap is open or torn.

Manufactured by:



Aurobindo Pharma Limited



Unit-VII (SEZ), Mahabubnagar (Dt)-509302, India .

For BluePoint Laboratories

Rev: 02/2023

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 (1-800-222-1222) right away

Active Ingredient in (each Tablet)

Famotidine USP 10 mg

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
Package Label Principal Display Panel

Aurobindo Pharma Limited. NDC: 68001-494-04

Famotidine Tablets USP 10mg 30s Label

Aurobindo Pharma Limited. NDC: 68001-494-04

Famotidine Tablets USP 10mg 30s Carton

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

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
Section 42229-5 (42229-5)

Drug Facts

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

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

Questions Or Comments? (Questions or Comments?)

call 1-855-274-4122

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

JUST ONE TABLET prevents and relieves heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages.







Do not use if carton is open or if printed foil seal under bottle cap is open or torn.

Manufactured by:



Aurobindo Pharma Limited



Unit-VII (SEZ), Mahabubnagar (Dt)-509302, India .

For BluePoint Laboratories

Rev: 02/2023

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 Breast Feeding (If Pregnant or Breast-Feeding)

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 (1-800-222-1222) right away

Active Ingredient in (each Tablet) (Active Ingredient in (Each Tablet))

Famotidine USP 10 mg

Ask A Doctor Before Use If You Have (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
Package Label Principal Display Panel (Package Label - Principal Display Panel)

Aurobindo Pharma Limited. NDC: 68001-494-04

Famotidine Tablets USP 10mg 30s Label

Aurobindo Pharma Limited. NDC: 68001-494-04

Famotidine Tablets USP 10mg 30s Carton

Ask A Doctor Or Pharmacist Before Use If You Are (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


Raw Label Data

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