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

Purpose

Antacid

Description

Calcium Carbonate 10 gr (648 mg)


Medication Information

Warnings


Active Ingredient

Calcium Carbonate 10 gr (648 mg)

Uses

relieves

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

Antacid

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

Description

Calcium Carbonate 10 gr (648 mg)

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

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.


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

Warnings


Active Ingredient (Active ingredient (in each tablet))

Calcium Carbonate 10 gr (648 mg)

Uses

relieves

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

Antacid

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

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

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.)


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

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