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Name:Alka-seltzer Heartburn
Manufacturer:Bayer Healthcare Llc, Consumer Care
Category:Over-the-counter (OTC) Marketed Drugs


Alka- Seltzer®HEARTBURN

ALKA-SELTZER HEARTBURN - anhydrous citric acid and sodium bicarbonate granule, effervescent 
Bayer HealthCare LLC, Consumer Care

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Alka-
Seltzer®
HEARTBURN

Drug Facts

Active ingredients (in each tablet) Purpose
Anhydrous citric acid 1000 mg Antacid
Sodium bicarbonate (heat-treated) 1940 mg Antacid

Uses

for the relief of

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

Warnings

Ask a doctor before use if you have a sodium-restricted diet

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 exceed recommended dosage

Stop use and ask a doctor if you have taken the maximum dose for 2 weeks

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

Keep out of reach of children.

Directions

  • fully dissolve 2 tablets in 4 ounces of water before taking
adults and children 12 years and over 2 tablets every 4 hours as needed, or as directed by a doctor do not exceed 8 tablets in 24 hours
adults 60 years and over 2 tablets every 4 hours as needed, or as directed by a doctor do not exceed 4 tablets in 24 hours
children under 12 years consult a doctor

Other information

  • each tablet contains: sodium 575 mg
  • phenylketonurics: contains phenylalanine 5.6 mg per tablet
  • store at room temperature. Avoid excessive heat.
  • Alka-Seltzer Heartburn in water contains the antacid sodium citrate as the principal active ingredient

Inactive ingredients

acesulfame potassium, aspartame, flavors, magnesium stearate, mannitol

Questions or comments?

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

PRINCIPAL DISPLAY PANEL - 36 Tablets Carton

Alka-
Seltzer
®

ANTACID MEDICINE

FAST, COOLING RELIEF OF:

&Heartburn
Acid Indigestion

LEMON
LIME

HEARTBURN

36 EFFERVESCENT
TABLETS

PRINCIPAL DISPLAY PANEL - 36 Tablets Carton

ALKA-SELTZER HEARTBURN 
anhydrous citric acid and sodium bicarbonate granule, effervescent
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-4085
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Anhydrous Citric Acid (Anhydrous Citric Acid) Anhydrous Citric Acid 1000 mg
Sodium Bicarbonate (Sodium Cation) Sodium Bicarbonate 1940 mg
Product Characteristics
Color WHITE Score     
Shape ROUND Size
Flavor Imprint Code ALKA;SELTZER;HR
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0280-4085-36 36 PACKET ( PACKET) in 1 CARTON contains a PACKET
1 1 GRANULE, EFFERVESCENT ( TABLET) in 1 PACKET This package is contained within the CARTON (0280-4085-36)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 03/02/2010

Labeler - Bayer HealthCare LLC, Consumer Care (785159372)

Revised: 03/2010 Bayer HealthCare LLC, Consumer Care



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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