Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID f21c8cf7-45cb-492b-bf4a-462024a54569
Route
ORAL
Published
Effective Date 2024-12-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: PH046 Shape: round Color: white Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-02-28

Description

Calcium Carbonate 10 gr (648 mg)

Purpose

Antacid


Medication Information

Purpose

Antacid

Description

Calcium Carbonate 10 gr (648 mg)

Uses

relieves

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach associated with these symptoms
Section 42229-5

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING

This is a bulk package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.

Section 51945-4

NDC 0536-1206-10

Rugby ®

Calcium

Carbonate

10 gr (648 mg)

ANTACID

1000 TABLETS

Warnings


Directions
  • take one to four tablets daily
  • do not take more than 4 tablets in 24 hours
  • do not use the maximum dosage for more than two weeks
Other Information
  • each tablet contains: calcium 260 mg
  • store at room temperature
Inactive Ingredients

acacia, croscarmellose sodium, magnesium stearate, maltodextrin, microcrystalline cellulose, stearic acid

Questions Or Comments?

(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

Stop Use and Ask A Doctor If

symptoms last more than 2 weeks.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.


Active Ingredient (in Each Tablet)

Calcium Carbonate 10 gr (648 mg)

Ask A Doctor Before Use If You Have
  • kidney stones
  • a calcium-restricted diet
Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug. Antacids may interact with certain prescription drugs.


Structured Label Content

Uses

relieves

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach associated with these symptoms
Section 42229-5 (42229-5)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING

This is a bulk package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.

Section 51945-4 (51945-4)

NDC 0536-1206-10

Rugby ®

Calcium

Carbonate

10 gr (648 mg)

ANTACID

1000 TABLETS

Purpose

Antacid

Warnings


Directions
  • take one to four tablets daily
  • do not take more than 4 tablets in 24 hours
  • do not use the maximum dosage for more than two weeks
Other Information (Other information)
  • each tablet contains: calcium 260 mg
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

acacia, croscarmellose sodium, magnesium stearate, maltodextrin, microcrystalline cellulose, stearic acid

Questions Or Comments? (Questions or comments?)

(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

symptoms last more than 2 weeks.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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


Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Calcium Carbonate 10 gr (648 mg)

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • kidney stones
  • a calcium-restricted diet
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking a prescription drug. Antacids may interact with certain prescription drugs.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)