first aid only antacid tablets

first aid only antacid tablets
SPL v2
SPL
SPL Set ID 68902dda-a13c-ff2e-e053-2991aa0a06b1
Route
oral
Published
Effective Date 2018-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
carbonate ion (420 mg)
Inactive Ingredients
aspartame croscarmellose sodium magnesium stearate maltodextrin mineral oil sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: AZ;036 Shape: round Color: white Size: 11 mm Score: 1
Marketing Status
otc monograph drug active Since 2014-06-15

Purpose

Antacid

Description

Drug Facts


Medication Information

Active Ingredient

Calcium Carbonate 420 mg

Uses

For the relief of the following symptoms associated with

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

Antacid

Directions
  • do not use more than directed
Other Information
  • Phenylketonurics: contains phenylalanine 1.5 mg per tablet
  • each tablet contains 168 mg of elemental calcium
  • store at room temperature 59-86°F (15-30°C) in a dry place
  • tamper-evident sealed packets
  • do not use any opened or torn packets
Inactive Ingredients

aspartame*, croscarmellose sodium*, gum acacia*, magnesium stearate, maltodextrin, mineral oil*, mint flavor, sorbitol*, sucrose*

* may contain

Description

Drug Facts

Section 42229-5

Drug Facts

Section 51945-4

First Aid Only Antacid Label

Section 53414-9

If you are pregnant or breast feeding,

ask a health profdessional before use.

Questions Or Comments?

Call 1-800-835-2263

Keep Out of the Reach of Children.

As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

Stop Using This Product and Ask A Doctor If
  • symptoms last more than 2 weeks

Ask A Doctor Or Phamacist Before Use If You Are
  • taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

  • do not take more than 19 tablets in 24 hours
  • do not use the maximum dosage for more than 2 weeks except under the advise and supervision of a physician
  • do not exceed recommended dosage

Structured Label Content

Active Ingredient (Active ingredient (in each tablet))

Calcium Carbonate 420 mg

Uses

For the relief of the following symptoms associated with

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

Antacid

Directions
  • do not use more than directed
Other Information (Other information)
  • Phenylketonurics: contains phenylalanine 1.5 mg per tablet
  • each tablet contains 168 mg of elemental calcium
  • store at room temperature 59-86°F (15-30°C) in a dry place
  • tamper-evident sealed packets
  • do not use any opened or torn packets
Inactive Ingredients (Inactive ingredients)

aspartame*, croscarmellose sodium*, gum acacia*, magnesium stearate, maltodextrin, mineral oil*, mint flavor, sorbitol*, sucrose*

* may contain

Section 42229-5 (42229-5)

Drug Facts

Section 51945-4 (51945-4)

First Aid Only Antacid Label

Section 53414-9 (53414-9)

If you are pregnant or breast feeding,

ask a health profdessional before use.

Questions Or Comments? (Questions or comments?)

Call 1-800-835-2263

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

As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

Stop Using This Product and Ask A Doctor If (Stop using this product and ask a doctor if)
  • symptoms last more than 2 weeks

Ask A Doctor Or Phamacist Before Use If You Are (Ask a doctor or phamacist before use if you are)
  • taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

  • do not take more than 19 tablets in 24 hours
  • do not use the maximum dosage for more than 2 weeks except under the advise and supervision of a physician
  • do not exceed recommended dosage

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)