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.

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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 Type HUMAN OTC DRUG Item Code (Source) NDC:0280-4095
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
calcium carbonate (UNII: H0G9379FGK) (calcium cation - UNII:2M83C4R6ZB) calcium carbonate 750 mg
Inactive Ingredients
Ingredient Name Strength
acacia (UNII: 5C5403N26O)  
yellow wax (UNII: 2ZA36H0S2V)  
pigment red 5 (UNII: 91OZU993LX)  
carnauba wax (UNII: R12CBM0EIZ)  
citric acid monohydrate (UNII: 2968PHW8QP)  
starch, corn (UNII: O8232NY3SJ)  
corn syrup (UNII: 9G5L16BK6N)  
.alpha.-tocopherol, dl- (UNII: 7QWA1RIO01)  
FD&C blue no. 1 (UNII: H3R47K3TBD)  
FD&C red no. 40 (UNII: WZB9127XOA)  
aluminum oxide (UNII: LMI26O6933)  
FD&C yellow no. 5 (UNII: I753WB2F1M)  
FD&C yellow no. 6 (UNII: H77VEI93A8)  
hydrogenated coconut oil (UNII: JY81OXM1OM)  
medium-chain triglycerides (UNII: C9H2L21V7U)  
methylparaben (UNII: A2I8C7HI9T)  
phosphoric acid (UNII: E4GA8884NN)  
propylparaben (UNII: Z8IX2SC1OH)  
propylene glycol (UNII: 6DC9Q167V3)  
water (UNII: 059QF0KO0R)  
shellac (UNII: 46N107B71O)  
sodium benzoate (UNII: OJ245FE5EU)  
sorbic acid (UNII: X045WJ989B)  
sorbitol (UNII: 506T60A25R)  
lecithin, soybean (UNII: 1DI56QDM62)  
sucrose (UNII: C151H8M554)  
titanium dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
Color ORANGE, YELLOW, PINK Score no score
Shape OVAL Size 18mm
Flavor ORANGE, LEMON, STRAWBERRY Imprint Code AS
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0280-4095-36 36 in 1 BOTTLE
2 NDC:0280-4095-60 60 in 1 BOTTLE
3 NDC:0280-4095-01 1 in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part331 03/15/2013
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