ALKA-SELTZER HEARTBURN RELIEFCHEWS STRAWBERRY AND ORANGE- calcium carbonate tablet, chewable

Alka-Seltzer Heartburn ReliefChews Strawberry and Orange by

Drug Labeling and Warnings

Alka-Seltzer Heartburn ReliefChews Strawberry and Orange by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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).

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, FD&C yellow #6, flavors, hydrogenated coconut oil, lecithin, medium chain triglycerides, methyl paraben, modified starch, phosphoric acid, pregelatinized modified starch, propylene glycol, propyl paraben, 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

SPL UNCLASSIFIED SECTION

Dist. by: Bayer HealthCare LLC
Whippany, NJ 07981

PRINCIPAL DISPLAY PANEL - 6 Tablet Blister Pack Carton

ON-THE-GO PACK

PEEL

strawberry & orange

Alka-

Seltzer ®

Calcium Carbonate /Antacid

EXTRA STRENGTH

HEARTBURN

RELIEFCHEWS ™

6 CHEWABLE

TABLETS

INGREDIENTS AND APPEARANCE

ALKA-SELTZER HEARTBURN RELIEFCHEWS STRAWBERRY AND ORANGE 
calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0280-0224
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
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)
METHYLPARABEN (UNII: A2I8C7HI9T)
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
Color	pink, orange	Score	no score
Shape	ROUND	Size	18mm
Flavor	STRAWBERRY, ORANGE	Imprint Code	AS
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0280-0224-06	1 in 1 CARTON	03/15/2014
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	03/15/2014

Labeler - Bayer HealthCare LLC. (112117283)