ALKA-SELTZER FRUIT CHEWS- calcium carbonate tablet, chewable 
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.

----------

Alka-Seltzer® Fruit Chews

Drug Facts

Active ingredient (in each chewable tablet)

Calcium carbonate 750 mg

Purpose

Antacid

Uses

for the relief of:

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

Other information

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 or comments?

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

Distributed by:
Bayer HealthCare LLC
P.O. Box 1910
Morristown, NJ 07962-1910 USA

PRINCIPAL DISPLAY PANEL - 36 Tablet Bottle Label

NEW!

Orange
Lemon
Strawberry

Alka-
Seltzer®

Calcium Carbonate /
Antacid

FRUIT CHEWS

FOR FAST RELIEF OF

36 CHEWABLE TABLETS

Principal Display Panel - 36 Tablet Bottle Label
ALKA-SELTZER FRUIT CHEWS 
calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0280-4095
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
calcium carbonate (calcium cation) calcium carbonate750 mg
Inactive Ingredients
Ingredient NameStrength
acacia 
yellow wax 
pigment red 5 
carnauba wax 
citric acid monohydrate 
starch, corn 
corn syrup 
.alpha.-tocopherol, dl- 
FD&C blue no. 1 
FD&C red no. 40 
aluminum oxide 
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 
Product Characteristics
ColorORANGE, YELLOW, PINKScoreno score
ShapeOVALSize18mm
FlavorORANGE, LEMON, STRAWBERRYImprint Code AS
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0280-4095-3636 in 1 BOTTLE
2NDC:0280-4095-6060 in 1 BOTTLE
3NDC:0280-4095-011 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33103/15/2013
Labeler - Bayer HealthCare LLC, Consumer Care (785159372)

Revised: 2/2013
Document Id: 948d8e04-288a-44c7-b884-c1578690313a
Set id: e09648f2-4b46-4461-8554-9c4866650f90
Version: 1
Effective Time: 20130208
 
Bayer HealthCare LLC, Consumer Care