Calmicid Ac Content Of Labeling

Calmicid Ac Content Of Labeling
SPL v7
SPL
SPL Set ID 9aed4009-307c-44ef-8dce-394a8d4c6597
Route
ORAL
Published
Effective Date 2011-02-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Famotidine (20 mg)
Inactive Ingredients
Carnauba Wax Silicon Dioxide Croscarmellose Sodium Lactose Monohydrate Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol Polyvinyl Alcohol Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: L194 Shape: round Color: white Size: 8 mm Score: 1
Marketing Status
ANDA Active Since 2011-01-20

Description

Purpose Acid reducer


Medication Information

Recent Major Changes

DO NOT USE IF PRINTED FOIL UNDER CAP IS BROKEN OR MISSING

Warnings and Precautions

Warnings

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

Indications and Usage

Use

  • 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

Dosage and Administration

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

Description

Purpose Acid reducer

Section 34072-9

Other information

  • read the directions and warnings before use
  • keep the carton, it contains important information.

Section 44425-7

Other information

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

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 50566-9

Stop use and ask a doctor if

  • your heartburn continues or worsens
  • you need to take this product for more than 14 days

Section 50569-3

Ask a doctor before use if you have

  • had heartburn over three 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

Section 50570-1

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

Section 51727-6

Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, lactose (monohydrrate), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide

Section 51945-4

Section 53413-1

Questions or comments?

1-800-282-3000

Section 53414-9

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1

Purpose

Acid reducer

Section 55106-9

Active ingredient (in each tablet)

Famotidine 20 mg


Structured Label Content

Recent Major Changes (34066-1)

DO NOT USE IF PRINTED FOIL UNDER CAP IS BROKEN OR MISSING

Indications and Usage (34067-9)

Use

  • 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

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Warnings

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

Section 34072-9 (34072-9)

Other information

  • read the directions and warnings before use
  • keep the carton, it contains important information.

Section 44425-7 (44425-7)

Other information

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

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 50566-9 (50566-9)

Stop use and ask a doctor if

  • your heartburn continues or worsens
  • you need to take this product for more than 14 days

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • had heartburn over three 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

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, lactose (monohydrrate), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

1-800-282-3000

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Acid reducer

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Famotidine 20 mg


Advanced Ingredient Data


Raw Label Data

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