Calcium Carbonate 750mg

Calcium Carbonate 750mg
SPL v1
SPL
SPL Set ID 2be44c62-a9a2-5646-e054-00144ff8d46c
Route
ORAL
Published
Effective Date 2014-07-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calcium Cation (750 mg)
Inactive Ingredients
Carnauba Wax

Identifiers & Packaging

Pill Appearance
Imprint: FC Shape: round Color: yellow Color: pink Color: orange Size: 70 mm
Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-07-18

Description

Calcium Carbonate 750mg


Medication Information

Warnings and Precautions

Warnings

Do not take more than 5 chews in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician.

Indications and Usage

Uses: Relieves

  • Heartburn
  • Sour Stomach
  • Acid Indigestion
  • Upset stomach due to these symptoms
Dosage and Administration

Directions

Adults and chldren 12 years and older chew and swallow 2 to 4 chews hourly if needed. Do not exceed 5 chews in 24 hours. Children under 12 years consult a doctor.

Description

Calcium Carbonate 750mg

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 50568-5

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

Section 51727-6

Inactive Ingredients:

Beeswax, carmine, carnauba wax, citric acid, corn syrup, DL-alpha tocopherol, ethyl acetate, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #5 lake (tartrazine), FD&C yellow #6, FD&C yellow #6 aluminum lake, gum arabic, hydrogenated coconut oil, medium chain triglycerides, methly paraben, modified corn starch, natural and artificial flavors, pregelatinized corn starch, propylene glycol, propyl paraben, phosphoric acid, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, sucrose, titanium dioxide

Soybean oil and corn starch used as processing aids.

Section 51945-4

Section 53413-1

Questions?

1-800-632-6900

Section 53414-9

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

Section 55105-1

Purpose

Antacid

Section 55106-9

Calcium Carbonate 750mg

Section 60561-8

Other information

Each chew contains: calcium 300mg, mangnesium 1mg

Contains: Soy

Store between 20C to 25C (68 to 77F) in a dry place


Structured Label Content

Indications and Usage (34067-9)

Uses: Relieves

  • Heartburn
  • Sour Stomach
  • Acid Indigestion
  • Upset stomach due to these symptoms
Dosage and Administration (34068-7)

Directions

Adults and chldren 12 years and older chew and swallow 2 to 4 chews hourly if needed. Do not exceed 5 chews in 24 hours. Children under 12 years consult a doctor.

Warnings and Precautions (34071-1)

Warnings

Do not take more than 5 chews in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician.

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 50568-5 (50568-5)

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

Section 51727-6 (51727-6)

Inactive Ingredients:

Beeswax, carmine, carnauba wax, citric acid, corn syrup, DL-alpha tocopherol, ethyl acetate, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #5 lake (tartrazine), FD&C yellow #6, FD&C yellow #6 aluminum lake, gum arabic, hydrogenated coconut oil, medium chain triglycerides, methly paraben, modified corn starch, natural and artificial flavors, pregelatinized corn starch, propylene glycol, propyl paraben, phosphoric acid, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, sucrose, titanium dioxide

Soybean oil and corn starch used as processing aids.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions?

1-800-632-6900

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Antacid

Section 55106-9 (55106-9)

Calcium Carbonate 750mg

Section 60561-8 (60561-8)

Other information

Each chew contains: calcium 300mg, mangnesium 1mg

Contains: Soy

Store between 20C to 25C (68 to 77F) in a dry place


Advanced Ingredient Data


Raw Label Data

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