Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 98041570-993e-4ab4-8565-1f8c0b5e433a
Route
ORAL
Published
Effective Date 2021-03-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calcium Cation (648 mg)
Inactive Ingredients
Croscarmellose Sodium Magnesium Stearate Cellulose, Microcrystalline Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: PH046 Shape: round Color: white Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2006-11-29

Description

Calcium carbonate 10 gr (648 mg, USP)

Purpose

Antacid


Medication Information

Purpose

Antacid

Description

Calcium carbonate 10 gr (648 mg, USP)

Uses

for relief of

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach associated with these symptoms
Section 51945-4

PHARBEST

NDC 16103-0377-11

Manufactured in the U.S.A.

Compare to Tums® active ingredient

Calcium

Carbonate

Antacid

Calcium Rich •Low Sodium Antacid

THIS PACKAGE FOR HOUSEHOLDS

WITHOUT YOUNG CHILDREN

1000 TABLETS

10 gr (648 mg)

Warnings


Direction
  • take two to four tablets as symptoms occur or as directed by a doctor
Other Information
  • each tablet contains: calcium 240 mg
  • store at controlled room temperature 150 to 300C (590 to 860F)
  • use by expiration date on package
Inactive Ingredients

croscarmellose sodium, magnesium stearate, microcrystalline cellulose, stearic acid

When Using This Prouct
  • do not take more than 10 tablets in 24 hours
  • do not use the maximum dosage for more than 2 weeks
Active Ingredient (in Each Tablet)

Calcium carbonate 10 gr (648 mg, USP)

Keep Out of the Reach of Children.


Ask A Doctor Before Use If You Have
  • kidney stone
  • a calcium-restricted diet
Questions? adverse Drug Event Call:

(866) 562-2756

Ask A Doctor Or Pharmacist Before Use If

you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.


Structured Label Content

Uses

for relief of

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach associated with these symptoms
Section 51945-4 (51945-4)

PHARBEST

NDC 16103-0377-11

Manufactured in the U.S.A.

Compare to Tums® active ingredient

Calcium

Carbonate

Antacid

Calcium Rich •Low Sodium Antacid

THIS PACKAGE FOR HOUSEHOLDS

WITHOUT YOUNG CHILDREN

1000 TABLETS

10 gr (648 mg)

Purpose

Antacid

Warnings


Direction
  • take two to four tablets as symptoms occur or as directed by a doctor
Other Information (Other information)
  • each tablet contains: calcium 240 mg
  • store at controlled room temperature 150 to 300C (590 to 860F)
  • use by expiration date on package
Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, magnesium stearate, microcrystalline cellulose, stearic acid

When Using This Prouct (When using this prouct)
  • do not take more than 10 tablets in 24 hours
  • do not use the maximum dosage for more than 2 weeks
Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Calcium carbonate 10 gr (648 mg, USP)

Keep Out of the Reach of Children. (Keep out of the reach of children.)


Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • kidney stone
  • a calcium-restricted diet
Questions? adverse Drug Event Call: (Questions? Adverse drug event call:)

(866) 562-2756

Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)

you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.


Advanced Ingredient Data


Raw Label Data

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