Alka-seltzer Heartburn Reliefchews Tablet, Chewable
FDA Label NDC 0280-0221

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bayer Healthcare Llc. for the product Alka-seltzer Heartburn Reliefchews (NDC 0280-0221). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each chewable tablet), purpose, uses, otc - do not use, otc - ask doctor/pharmacist, when using this product, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Dist. by:
Bayer HealthCare LLC
Whippany, NJ 07981

Active Ingredient (In Each Chewable Tablet)

Calcium carbonate 750 mg

Purpose

Antacid

Uses

for the relief of:

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

Otc - Do Not Use

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

Otc - Ask Doctor/Pharmacist

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

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

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

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

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

Questions?

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

Principal Display Panel - 36 Tablet Bottle Label

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Alka-
Seltzer ®
Calcium Carbonate /
Antacid

assorted fruit

HEARTBURN
RELIEFCHEWS™

Fast Powerful Relief of
• Heartburn • Acid Indigestion
• Upset Stomach

36 CHEWABLE TABLETS

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