ALKA-SELTZER HEARTBURN RELIEF EXTRA STRENGTH (anhydrous citric acid, sodium bicarbonate- heat-treated tablet, effervescent

Alka-Seltzer Heartburn Relief Extra Strength by

Drug Labeling and Warnings

Alka-Seltzer Heartburn Relief Extra Strength by is a Otc medication manufactured, distributed, or labeled by Bayer Healthcare LLC, Bayer de Mexico, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Anhydrous citric acid 1000 mg

Sodium bicarbonate (heat-treated) 1976 mg

PURPOSE

Antacid

Antacid

INDICATIONS & USAGE

Uses for the relief of

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

WARNINGS

Warnings

DO NOT USE

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

ASK DOCTOR

Ask a doctor before use if you have a sodium-restricted diet

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 exceed recommended dosage

STOP USE

Stop use and ask a doctor if you have taken the maximum dose for 2 weeks

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

● fully dissolve 2 tablets in 4 ounces of water before taking

adults and children 12 years and over	2 tablets every 4 hours as needed, or as directed by a doctor	do not exceed 8 tablets in 24 hours
adults 60 years and over	2 tablets every 4 hours as needed, or as directed by a doctor	do not exceed 4 tablets in 24 hours
children under 12 years	consult a doctor

OTHER SAFETY INFORMATION

Other information

● each tablet contains: sodium 586 mg
● store at room temperature. Avoid excessive heat.
● Alka-Seltzer Extra Strength in water contains the antacid
sodium citrate as the principal active ingredient

INACTIVE INGREDIENT

Inactive ingredients

magnesium stearate, mannitol

QUESTIONS

Questions or comments? 1-800-986-0369 (Mon – Fri 9AM – 5PM EST)

PRINCIPAL DISPLAY PANEL

​ALKA-SELTZER

Fast 4-in-1

Relief of:

Heartburn

Sour Stomach

Acid Indigestion

Upset Stomach

HEARTBURN RELIEF

EXTRA STRENGTH

24 EFFERVESCENT TABLETS

(12 - 2 count pouches)

INGREDIENTS AND APPEARANCE

ALKA-SELTZER HEARTBURN RELIEF EXTRA STRENGTH 
anhydrous citric acid, sodium bicarbonate (heat-treated) tablet, effervescent

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0280-0079
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM BICARBONATE	1976 mg
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	1000 mg

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)

Product Characteristics
Color	white	Score	score with uneven pieces
Shape	ROUND	Size	25mm
Flavor		Imprint Code	ALKA;SELTZER;EX;S
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0280-0079-01	12 in 1 CARTON	09/21/2021
1		2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 0280-0079-02	36 in 1 CARTON	05/23/2023
2		2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M001	09/21/2021

Labeler - Bayer Healthcare LLC (112117283)