Heartburn Relief

Heartburn Relief
SPL v1
SPL
SPL Set ID 84a9a761-7d6f-4e63-814f-e7a71e0ff11b
Route
ORAL
Published
Effective Date 2013-08-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Famotidine (10 mg)
Inactive Ingredients
Hydroxypropyl Cellulose (type H) Talc Ferric Oxide Red Polyethylene Glycol 400 Cellulose, Microcrystalline Water Magnesium Stearate Hypromelloses Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: W972 Shape: oval Color: pink Size: 8 mm Score: 1
Marketing Status
ANDA Active Since 2013-08-19

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

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use

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 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
Allergy Alert

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

Other Information
  • store at 25°-30°C (77°-86°F).
  • read the directions and warnings before use
  • protect from moisture.
  • keep the carton and package insert. They contain important information.
Inactive Ingredients

hydroxypropyl cellulose, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxide

Questions Or Comments?

1-800-xxx-xxxx

Stop Use and Ask A Doctor If
  • your heartburn continues or worsens
  • you need to take this product for more than 14 days
Active Ingredient (in Each Tablet)

Famotidine USP 10mg

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
Principal Display Panel 12 Tablet Blister Pack Carton

ASSURED

Compare to the

active ingredient

in Pepcid® AC*

Original Strength

HEARTBURN

RELIEF

FAMOTIDINE TABLETS USP, 10 mg

ACID REDUCER

Just One Tablet Relieves &

Prevents Heartburn Due to

Acid Indigestion

12 TABLETS (12 DOSES)


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

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use

Purpose

Acid reducer

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 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
Allergy Alert (Allergy alert)

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

Other Information (Other information)
  • store at 25°-30°C (77°-86°F).
  • read the directions and warnings before use
  • protect from moisture.
  • keep the carton and package insert. They contain important information.
Inactive Ingredients (Inactive ingredients)

hydroxypropyl cellulose, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-800-xxx-xxxx

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

Famotidine USP 10mg

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
Principal Display Panel 12 Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 12 Tablet Blister Pack Carton)

ASSURED

Compare to the

active ingredient

in Pepcid® AC*

Original Strength

HEARTBURN

RELIEF

FAMOTIDINE TABLETS USP, 10 mg

ACID REDUCER

Just One Tablet Relieves &

Prevents Heartburn Due to

Acid Indigestion

12 TABLETS (12 DOSES)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)