Calmicid Ac

Calmicid Ac
SPL v1
SPL
SPL Set ID 369ae213-cd23-57ba-e063-6394a90a87a6
Route
ORAL
Published
Effective Date 2011-01-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Shape: round Color: white Size: 8 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-01-20

Description

Active ingredient (in each tablet) Famotidine 20mg


Medication Information

Warnings and Precautions

Warnings

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

Indications and Usage

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

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

Active ingredient (in each tablet) Famotidine 20mg

Section 44425-7

Other Information

■ read the directions and warnings before use

■ keep the carton. It contains important 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 50569-3

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

■ your heartburn continues or worsens

■ you need to take this product for more than 14 days

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 (monohydrate), 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 breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

Acid Reducer

Section 55106-9

Active ingredient (in each tablet)

Famotidine 20mg


Structured Label Content

Indications and Usage (34067-9)

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

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 44425-7 (44425-7)

Other Information

■ read the directions and warnings before use

■ keep the carton. It contains important 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 50569-3 (50569-3)

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

■ your heartburn continues or worsens

■ you need to take this product for more than 14 days

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 (monohydrate), 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 breast-feeding, 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 20mg


Advanced Ingredient Data


Raw Label Data

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