drug facts

drug facts
SPL v2
SPL
SPL Set ID fce6c50d-908f-44a6-ba63-ece813f3711b
Route
oral
Published
Effective Date 2024-11-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
calcium cation (500 mg)
Inactive Ingredients
adipic acid d&c red no. 27 d&c yellow no. 10 dextrose, unspecified form fd&c blue no. 1 fd&c yellow no. 6 magnesium stearate maltodextrin starch, corn sucralose

Identifiers & Packaging

Pill Appearance
Imprint: RP101 Shape: round Color: red Color: yellow Color: orange Size: 16 mm Score: 1
Marketing Status
otc monograph drug active Since 2024-11-11

Purpose

Antacid

Description

Calcium carbonates USP 500mg


Medication Information

Warnings

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

When using this product

  • do not take more than 15 tablets in 24 hours
  • If pregnant do not take more than 10 tablets in 24 hours.
  • do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor.
Uses

relieves:

  • heartburn
  • sour stomach
  • acid indigestion
  • upset stomach associated with these symptoms
Purpose

Antacid

Directions
  • adults and children 12 years of age and over: Chew 2-4 tablets completely as symptoms occur, or as directed by a doctor.
  • Do not swallow tablets whole
  • Do not take for symptoms that persist for more than 2 weeks unless advised by a doctor.
Other Information
  • each tablet contains: Calcium 200mg
  • Store below 30°C (86°F).
  • Keep the container tightly closed
Inactive Ingredients

adipic acid, D&C Red No. 27, D&C Yellow No. 10 Lake, dextrose, FD&C Blue No. 1 Lake, FD&C Yellow No. 6 Lake, flavors, magnesium stearate, maltodextrin, starch, sucralose.

SAFETY SEALED: DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING.

Description

Calcium carbonates USP 500mg

Active Ingredient

Calcium carbonates USP 500mg

Questions Or Comments?

1-866-467-2748

Package/label Principal Display Panel

Compare to the active ingredients in Regular Strength Tums®

NDC 83324-315-15

Quality Choice

Regular Strength

Antacid Tablets

Calcium Carbonate 500mg

Relieves:

Upset Stomach

Heartburn

Acid Indigestion

Assorted Fruit

Naturally and artificially Flavored

150 Chewable Tablets

GLUTEN-FREE

Distributed by CDMA, INC

Novi, MI 48375

www.qualitychoice .com

Questions: 800-935-2362

*This product is not manufactured or distributed by GlaxoSmithKline LLC, owner of the registered trademark, Regular Strength Tums®

Quality Choice Regular Strength Antacid Tablets


Structured Label Content

Warnings

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

When using this product

  • do not take more than 15 tablets in 24 hours
  • If pregnant do not take more than 10 tablets in 24 hours.
  • do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor.
Uses

relieves:

  • heartburn
  • sour stomach
  • acid indigestion
  • upset stomach associated with these symptoms
Purpose

Antacid

Directions
  • adults and children 12 years of age and over: Chew 2-4 tablets completely as symptoms occur, or as directed by a doctor.
  • Do not swallow tablets whole
  • Do not take for symptoms that persist for more than 2 weeks unless advised by a doctor.
Other Information
  • each tablet contains: Calcium 200mg
  • Store below 30°C (86°F).
  • Keep the container tightly closed
Inactive Ingredients (Inactive ingredients)

adipic acid, D&C Red No. 27, D&C Yellow No. 10 Lake, dextrose, FD&C Blue No. 1 Lake, FD&C Yellow No. 6 Lake, flavors, magnesium stearate, maltodextrin, starch, sucralose.

SAFETY SEALED: DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING.

Active Ingredient (Active ingredient)

Calcium carbonates USP 500mg

Questions Or Comments? (Questions or comments?)

1-866-467-2748

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Compare to the active ingredients in Regular Strength Tums®

NDC 83324-315-15

Quality Choice

Regular Strength

Antacid Tablets

Calcium Carbonate 500mg

Relieves:

Upset Stomach

Heartburn

Acid Indigestion

Assorted Fruit

Naturally and artificially Flavored

150 Chewable Tablets

GLUTEN-FREE

Distributed by CDMA, INC

Novi, MI 48375

www.qualitychoice .com

Questions: 800-935-2362

*This product is not manufactured or distributed by GlaxoSmithKline LLC, owner of the registered trademark, Regular Strength Tums®

Quality Choice Regular Strength Antacid Tablets


Advanced Ingredient Data


Raw Label Data

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