Alka-seltzer ®

Alka-seltzer ®
SPL v9
SPL
SPL Set ID bdb43d3b-ddcd-4359-a174-a5556e7c5f57
Route
ORAL
Published
Effective Date 2014-03-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calcium Cation (750 mg)
Inactive Ingredients
Yellow Wax Acacia Carnauba Wax Citric Acid Monohydrate Starch, Corn Corn Syrup .alpha.-tocopherol, Dl- Fd&c Blue No. 1 Aluminum Oxide Fd&c Red No. 40 Fd&c Yellow No. 5 Fd&c Yellow No. 6 Hydrogenated Coconut Oil Medium-chain Triglycerides Methylparaben Phosphoric Acid Propylparaben Propylene Glycol Water Shellac Sodium Benzoate Sorbic Acid Sorbitol Lecithin, Soybean Sucrose Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: AS Shape: round Color: yellow Color: orange Color: pink Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-03-15

Description

Drug Facts

Purpose

Antacid


Medication Information

Purpose

Antacid

Description

Drug Facts

Uses

for the relief of:

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

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50568-5

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

Section 50570-1

Do not use if you have ever had an allergic reaction to this product or any of its ingredients

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Directions
  • adults and children 12 years and over: chew and swallow 1-2 chewable tablets every 2 to 4 hours as symptoms occur, or as directed by a doctor
  • children under 12 years: consult a doctor
  • do not take more than 10 chewable tablets in a 24-hour period
Questions?

1-800-986-0369 (Mon – Fri 9AM – 5PM EST) or www.alkaseltzer.com

Other Information
  • each chewable tablet contains: calcium 300 mg
  • contains FD&C Yellow No. 5 (tartrazine) as a color additive
  • store at room temperature. Avoid humidity. Close cap tightly after use.
Inactive Ingredients

acacia, beeswax, carmine, carnauba wax, citric acid, corn starch, corn syrup, DL-alpha tocopherol, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #5 lake (tartrazine), FD&C yellow #6, FD&C yellow #6 aluminum lake, FD&C yellow #6 lake, flavors, hydrogenated coconut oil, medium chain triglycerides, methyl paraben, modified starch, phosphoric acid, pregelatinized modified starch, propyl paraben, propylene glycol, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, sucrose, titanium dioxide

When Using This Product
  • do not take more than 10 chewable tablets in a 24-hour period
  • do not use the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a physician
  • constipation may occur
Active Ingredient (in Each Chewable Tablet)

Calcium carbonate 750 mg

Principal Display Panel 36 Tablet Bottle Label

assorted fruit

Alka-



Seltzer
®



Calcium Carbonate /



Antacid

EXTRA STRENGTH

HEARTBURN



RELIEFCHEWS™

Fast Powerful Relief

36 CHEWABLE TABLETS


Structured Label Content

Uses

for the relief of:

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

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50568-5 (50568-5)

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

Section 50570-1 (50570-1)

Do not use if you have ever had an allergic reaction to this product or any of its ingredients

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Antacid

Directions
  • adults and children 12 years and over: chew and swallow 1-2 chewable tablets every 2 to 4 hours as symptoms occur, or as directed by a doctor
  • children under 12 years: consult a doctor
  • do not take more than 10 chewable tablets in a 24-hour period
Questions?

1-800-986-0369 (Mon – Fri 9AM – 5PM EST) or www.alkaseltzer.com

Other Information (Other information)
  • each chewable tablet contains: calcium 300 mg
  • contains FD&C Yellow No. 5 (tartrazine) as a color additive
  • store at room temperature. Avoid humidity. Close cap tightly after use.
Inactive Ingredients (Inactive ingredients)

acacia, beeswax, carmine, carnauba wax, citric acid, corn starch, corn syrup, DL-alpha tocopherol, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #5 lake (tartrazine), FD&C yellow #6, FD&C yellow #6 aluminum lake, FD&C yellow #6 lake, flavors, hydrogenated coconut oil, medium chain triglycerides, methyl paraben, modified starch, phosphoric acid, pregelatinized modified starch, propyl paraben, propylene glycol, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, sucrose, titanium dioxide

When Using This Product (When using this product)
  • do not take more than 10 chewable tablets in a 24-hour period
  • do not use the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a physician
  • constipation may occur
Active Ingredient (in Each Chewable Tablet) (Active ingredient (in each chewable tablet))

Calcium carbonate 750 mg

Principal Display Panel 36 Tablet Bottle Label (PRINCIPAL DISPLAY PANEL - 36 Tablet Bottle Label)

assorted fruit

Alka-



Seltzer
®



Calcium Carbonate /



Antacid

EXTRA STRENGTH

HEARTBURN



RELIEFCHEWS™

Fast Powerful Relief

36 CHEWABLE TABLETS


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)