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Alka-Seltzer Heartburn ReliefChews: Drug Information and Usage Instructions, Study notes of Biochemistry

Detailed information about alka-seltzer heartburn reliefchews, an over-the-counter antacid medication. It includes the drug facts, warnings, directions for use, and a list of inactive ingredients. Users can find contact information for questions and additional product details.

Typology: Study notes

2021/2022

Uploaded on 09/27/2022

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ALKA- SELT ZER HEARTBURN RELIEFCHEWS- c alcium c arbonate tablet, che wable
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.
----------
Alka-Se ltzer Heartburn ReliefChews
Drug Facts
Active ingredient (in e ach chewable tablet)
Calc ium carbo nate 750 mg
Purpose
Antacid
Us es
for the relief of:
acid indige stio n
heartburn
so ur stomach
upse t stomach associated with these symptoms
Warnings
Do not us e if you have ever had an allergic reac tion to this pro duct or any of its ingr edients
As k a do cto r or pharmacist before use if you are presently taking a prescri ption drug . Antacids may
interact with certain pre sc ription drug s.
When using this product
do not take more than 10 che wable 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
supe rvisio n of a phys ician
co nstipation may occ ur
If pregnant or bre as t-feeding, ask a health profes sional before use.
Keep out o f reach of c hildren.
Direc tions
adults and chi ldren 12 years and over: che w and swallow 1-2 c hew able tablets every 2 to 4 hours as
symptoms occur, or as dir ec ted by a do cto r
childre n under 12 years: co nsult a doctor
do not take more than 10 che wable tablets in a 24-hour period
Other information
eac h chewable tablet co ntains : calcium 300 mg
co ntains FD&C Yellow No . 5 (tartrazine) as a color additive
®
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ALKA-SELTZER HEARTBURN RELIEFCHEWS- 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.

Alka-Seltzer Heartburn ReliefChews ™

Drug Facts

Active ingredient (in each chewable tablet)

Calcium carbonate 750 mg

Purpos e

Antacid

Us es

for the relief of:

acid indigestion

heartburn

sour stomach

upset stomach associated with these symptoms

Warnings

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

As k a doctor or pharmacis t before us e if you are presently taking a prescription drug. Antacids may

interact with certain prescription drugs.

When us ing 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 breas t-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

contains FD&C Yellow No. 5 (tartrazine) as a color additive

store at room temperature. Avoid humidity. Close cap tightly after use.

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

Ques tions?

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

Dist. by:

Bayer HealthCare LLC

Whippany, NJ 07981

PRINCIPAL DISPLAY PANEL - 36 Tablet Bottle Label

assorted fruit

Alka-

Seltzer

Calcium Carbonate /

Antacid

EXTRA STRENGTH

HEARTBURN

RELIEFCHEWS™

Fas t Powerful Relief

36 CHEWABLE TABLETS

Bayer HealthCare LLC.

METHYLPARABEN (UNII: A2I8 C7HI9 T)
PHO SPHO RIC ACID (UNII: E4GA8 8 8 4NN)
PRO PYLPARABEN (UNII: Z8 IX2SC1O H)
PRO PYLENE GLYCO L (UNII: 6 DC9 Q 16 7V3)
WATER (UNII: 0 59 Q F0 KO 0 R)
SHELLAC (UNII: 46 N10 7B71O )
SO DIUM BENZO ATE (UNII: O J245FE5EU)
SO RBIC ACID (UNII: X0 45WJ9 8 9 B)
SO RBITO L (UNII: 50 6 T6 0 A25R)
LECITHIN, SO YBEAN (UNII: 1DI56 Q DM6 2)
SUCRO SE (UNII: C151H8 M554)
TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color ye llo w, o ra nge , pink^ S core no sc o re

S hap e RO UND^ S iz e 18 mm

Flavor LEMO N, O RANGE, STRAWBERRY^ Imp rint Cod e AS

Contains

Packag ing

# Item Co de Packag e Descriptio n Marketing Start

Date

Marketing End

Date

1 NDC:0 28 0 -0 221-

36 in 1 BO TTLE, PLASTIC; Type 0 : No t a Co mbina tio n Pro duc t

2 NDC:0 28 0 -0 221- 6 0^ 6 0 Pro duc t^ in 1 BO TTLE, PLASTIC; Type 0 : No t a Co mbina tio n 0 3/15/20 14 3 NDC:0 28 0 -0 221- 12 120 in 1 BO TTLE, PLASTIC; Type 0 : No t a Co mbina tio n Pro duc t

4 NDC:0 28 0 -0 221- 9 0^ 9 0 Pro duc t^ in 1 BO TTLE, PLASTIC; Type 0 : No t a Co mbina tio n 0 8 /12/20 15 5 NDC:0 28 0 -0 221- 0 8 8 in 1 PO UCH; Type 0 : No t a Co mbina tio n Pro duc t 0 3/23/20 16 6 NDC:0 28 0 -0 221- 0 1^32 Pro duc t^ in 1 BO TTLE, PLASTIC; Type 0 : No t a Co mbina tio n 0 3/0 1/20 20 7 NDC:0 28 0 -0 221- 0 2^ 6 6 Pro duc t^ in 1 BO TTLE, PLASTIC; Type 0 : No t a Co mbina tio n 0 3/0 1/20 20

Marketing Information

Marke ting Cate gory Ap p lication Numb e r or Monograp h Citation Marke ting S tart Date Marke ting End Date

O TC mo no gra ph fina l pa rt331 0 3/15/20 14

Labeler - Bayer HealthCare LLC. (112117283)

Revised: 1/