Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 011bf4be-5e8c-47ae-9fbd-2b01da32696a
Route
ORAL
Published
Effective Date 2011-12-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Carbonate Ion (500 mg)
Inactive Ingredients
Sucrose Starch, Corn Talc Mineral Oil Calcium Stearate Adipic Acid Fd&c Yellow No. 5 Fd&c Yellow No. 6 D&c Red No. 6 D&c Red No. 30 D&c Red No. 27 Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Imprint: CALCID Shape: round Color: orange Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-12-30

Description

Active Ingredient (per tablet) Calcium carbonate USP 500 mg


Medication Information

Warnings and Precautions
Warnings

Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs





Indications and Usage
Uses relieves: heartburn, sour stomach, acid indigestion, upset stomach associated with these symptoms
Dosage and Administration

Directions Antacid

-chew 2-4 tablets as symptoms occur or as directed by a doctor



Description

Active Ingredient (per tablet) Calcium carbonate USP 500 mg

Section 42229-5

Other information

- for calcium content see Supplement Facts.

- Store below30°C (86°F)

- do not use if printed seal under cap is torn or missing



CALCIUM SUPPLEMENT

Uses:
As a daily source of extra calcium

Directions: chew 2 tablets twice daily with meal



Supplement Facts

Serving Size: 2 Tablets

Servings Per Container: 50



Amount              %Daily

Per Serving         Value

Calories 5

Sugars 1g

Calcium 400mg     40%

Section 50565-1
Keep out of reach of children





Section 50567-7
When using this product

-do not take more than 15 tablets in 24 hours

-do not use the maximum dosage for more than 2 weeks

Section 51727-6

I nactive Ingredients

sucrose, calcium carbonate, corn starch, talc, mineral oil, calcium sterate, natural flavor and artificial flavor, adpic acid, Yellow No. 5, Yellow No. 6, Red No. 6, Red No. 30, Red No. 27 and Blue No. 1

Section 51945-4
Package Label



Section 53413-1
Questions? 1-877 2198302

Section 55105-1
Purpose

Antacid





Section 55106-9
Active Ingredient (per tablet)

Calcium carbonate USP 500 mg






Structured Label Content

Indications and Usage (34067-9)
Uses relieves: heartburn, sour stomach, acid indigestion, upset stomach associated with these symptoms
Dosage and Administration (34068-7)

Directions Antacid

-chew 2-4 tablets as symptoms occur or as directed by a doctor



Warnings and Precautions (34071-1)
Warnings

Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs





Section 42229-5 (42229-5)

Other information

- for calcium content see Supplement Facts.

- Store below30°C (86°F)

- do not use if printed seal under cap is torn or missing



CALCIUM SUPPLEMENT

Uses:
As a daily source of extra calcium

Directions: chew 2 tablets twice daily with meal



Supplement Facts

Serving Size: 2 Tablets

Servings Per Container: 50



Amount              %Daily

Per Serving         Value

Calories 5

Sugars 1g

Calcium 400mg     40%

Section 50565-1 (50565-1)
Keep out of reach of children





Section 50567-7 (50567-7)
When using this product

-do not take more than 15 tablets in 24 hours

-do not use the maximum dosage for more than 2 weeks

Section 51727-6 (51727-6)

I nactive Ingredients

sucrose, calcium carbonate, corn starch, talc, mineral oil, calcium sterate, natural flavor and artificial flavor, adpic acid, Yellow No. 5, Yellow No. 6, Red No. 6, Red No. 30, Red No. 27 and Blue No. 1

Section 51945-4 (51945-4)
Package Label



Section 53413-1 (53413-1)
Questions? 1-877 2198302

Section 55105-1 (55105-1)
Purpose

Antacid





Section 55106-9 (55106-9)
Active Ingredient (per tablet)

Calcium carbonate USP 500 mg






Advanced Ingredient Data


Raw Label Data

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