ALKA SELTZER- calcium carbonate tablet, chewable

Alka Seltzer by

Drug Labeling and Warnings

Alka Seltzer by is a Otc medication manufactured, distributed, or labeled by BestCo Inc., Bayer. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each chewable tablet)

Calcium carbonate 750 mg

PURPOSE

Purpose

Antacid

INDICATIONS & USAGE

Uses for the relief of:

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

WARNINGS

Warnings

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

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

When using this product

• do not take more than 5 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

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

DOSAGE & ADMINISTRATION

Directions

• adults and children 12 years and over: fully chew then swallow 1 or 2 chewable tablets as symptoms occur, or as directed by a doctor
• children under 12 years: consult a doctor
• do not take more than 5 chewable tablets in a 24-hour period

OTHER SAFETY INFORMATION

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 INGREDIENT

Inactive ingredients

acacia, carmine, carnauba wax, citric acid, corn starch, corn syrup, DL-alpha tocopherol, FD&C blue #1 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, hydrogenated vegetable oil, lecithin, medium chain triglycerides, methyl paraben, modified starch, phosphoric acid, pregelatinized modified starch, propyl paraben, propylene glycol, shellac, sodium benzoate, sorbic acid, sorbitol, sugar, titanium dioxide, water, white wax

QUESTIONS

Questions or comments?

1-800-986-0369 (Mon-Fri 9AM-5PM EST)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALKA SELTZER 
calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52642-226
Route of Administration	ORAL

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
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	pink, yellow, orange	Score	score with uneven pieces
Shape	ROUND	Size	70mm
Flavor	STRAWBERRY, LEMON, ORANGE	Imprint Code	AS
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52642-226-90	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/08/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	02/08/2013

Labeler - BestCo Inc. (002149136)

Registrant - Bayer (112117283)

Establishment
Name	Address	ID/FEI	Business Operations
BestCo Inc.		002149136	manufacture(52642-226)