ALKA-SELTZER HEARTBURN RELIEFCHEWS STRAWBERRY- calcium carbonate tablet, chewable 
Bayer HealthCare LLC.

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 ReliefChews™ Strawberry

Drug Facts

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

Warnings

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

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

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

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
  • store at room temperature. Avoid excessive heat above 40°C (104°F).
  • close cap tightly after use

Inactive ingredients

acacia, carmine, carnauba wax, citric acid, corn starch, corn syrup, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, flavors, hydrogenated coconut oil, lecithin, medium chain triglycerides, modified starch, phosphoric acid, pregelatinized modified starch, propylene glycol, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, sucrose, titanium dioxide, vegetable oil, white wax

Questions or comments?

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

Dist. by: Bayer HealthCare LLC
Whippany, NJ 07981

PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Label

OFFICIAL SPONSOR

Alka-
Seltzer ®
Calcium Carbonate /
Antacid

strawberry

HEARTBURN
RELIEFCHEWS™

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

60 CHEWABLE TABLETS

Principal Display Panel - 60 Tablet Bottle Label
ALKA-SELTZER HEARTBURN RELIEFCHEWS STRAWBERRY 
calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0223
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE750 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA (UNII: 5C5403N26O)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
STARCH, CORN (UNII: O8232NY3SJ)  
CORN SYRUP (UNII: 9G5L16BK6N)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SHELLAC (UNII: 46N107B71O)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBIC ACID (UNII: X045WJ989B)  
SORBITOL (UNII: 506T60A25R)  
SUCROSE (UNII: C151H8M554)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WHITE WAX (UNII: 7G1J5DA97F)  
Product Characteristics
ColorpinkScoreno score
ShapeROUNDSize18mm
FlavorSTRAWBERRYImprint Code AS
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0280-0223-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/15/201408/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33103/15/201408/31/2017
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 5/2017
Document Id: 4fba58d3-a10b-747c-e054-00144ff8d46c
Set id: 8505387b-2702-4fb1-afc0-3cd006d81f58
Version: 2
Effective Time: 20170517
 
Bayer HealthCare LLC.