Premier Value®

Premier Value®
SPL v4
SPL
SPL Set ID 42d1e2f2-9b9b-4a6d-9fc1-047e167153b5
Route
ORAL
Published
Effective Date 2019-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Famotidine (10 mg)
Inactive Ingredients
Silicon Dioxide Hydroxypropyl Cellulose (1600000 Wamw) Hypromellose, Unspecified Ferric Oxide Red Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol 400 Starch, Corn Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 036 Shape: round Color: pink Color: white Size: 8 mm Score: 1
Marketing Status
ANDA Active Since 2010-07-23

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 (1-800-222-1222).

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 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
  • with other acid reducers
  • if you have kidney disease, except under the advice and supervision of a doctor
  • 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.
Questions?

call 1-800-406-7984

Allergy Alert

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

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

colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxide

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 20 mg

Ask A Doctor Before Use If You Have
  • frequent chest pain
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain
  • 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
Principal Display Panel 25 Tablet Bottle Label

Premier

Value ®

MAXIMUM STRENGTH

Famotidine Tablets, USP 20 mg

Acid

Controller

Acid Reducer

  • Just One Tablet

    Prevents & Relieves Heartburn

    Due to Acid Indigestion

25 Tablets

INDEPENDENTLY TESTED

PV

SATISFACTION GUARANTEED

Principal Display Panel 25 Tablet Bottle Carton

COMPARE TO THE ACTIVE INGREDIENT

IN MAXIMUM STRENGTH PEPCID AC®

Premier

Value ®

MAXIMUM STRENGTH

Famotidine Tablets, USP 20 mg

Acid Controller

Acid Reducer

  • Just One Tablet

    Prevents & Relieves Heartburn

    Due to Acid Indigestion

25 Tablets

INDEPENDENTLY TESTED

PV

SATISFACTION GUARANTEED


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 (1-800-222-1222).

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 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)
  • with other acid reducers
  • if you have kidney disease, except under the advice and supervision of a doctor
  • 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.
Questions?

call 1-800-406-7984

Allergy Alert (Allergy alert)

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

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

colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxide

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 20 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • frequent chest pain
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain
  • 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
Principal Display Panel 25 Tablet Bottle Label (PRINCIPAL DISPLAY PANEL - 25 Tablet Bottle Label)

Premier

Value ®

MAXIMUM STRENGTH

Famotidine Tablets, USP 20 mg

Acid

Controller

Acid Reducer

  • Just One Tablet

    Prevents & Relieves Heartburn

    Due to Acid Indigestion

25 Tablets

INDEPENDENTLY TESTED

PV

SATISFACTION GUARANTEED

Principal Display Panel 25 Tablet Bottle Carton (PRINCIPAL DISPLAY PANEL - 25 Tablet Bottle Carton)

COMPARE TO THE ACTIVE INGREDIENT

IN MAXIMUM STRENGTH PEPCID AC®

Premier

Value ®

MAXIMUM STRENGTH

Famotidine Tablets, USP 20 mg

Acid Controller

Acid Reducer

  • Just One Tablet

    Prevents & Relieves Heartburn

    Due to Acid Indigestion

25 Tablets

INDEPENDENTLY TESTED

PV

SATISFACTION GUARANTEED


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)