ALKA SELTZER ORIGINAL- anhydrous citric acid, aspirin, sodium bicarbonate tablet, effervescent

Alka Seltzer Original by

Drug Labeling and Warnings

Alka Seltzer Original by is a Otc medication manufactured, distributed, or labeled by Savings Distributors LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each tablet)

Anhydrous citric acid 1000 mg

Aspirin 325 mg (NSAID)*

Sodium bicarbonate (heat-treated) 1916 mg

*nonsteroidal anti-inflammatory drug

Purposes

Antacid

Analgesic

Antacid

Uses

for the temporary relief of:

• heartburn, acid indigestion, and sour stomach when accompanied with headache or body aches and pains
• upset stomach with headache from overindulgence in food or drink
• headache, body aches, and pain alone

Warnings

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
are age 60 or older
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
have 3 or more alcoholic drinks every day while using this product
take more or for a longer time than directed

Do not use

if you are allergic to aspirin or any other pain reliever/fever reducer
if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if

stomach bleeding warning applies to you
you have a history of stomach problems, such as heartburn
you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
you are taking a diuretic
you have asthma
you have a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

presently taking a prescription drug (antacids may interact with certain prescription drugs)
taking a prescription drug for diabetes, gout, or arthritis

When using this product

do not exceed recommended dosage

Stop use and ask a doctor if

an allergic reaction occurs.Seek medical help right away
you experience any of the following signs of stomach bleeding
feel faint vomit blood have bloody or black stools have stomach pain that does not get better
symptoms get worse or last more than 10 days
redness or swelling is present
ringing in the ears or a loss of hearing occurs
new symptoms occur

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

fully dissolve 2 tablets in 4 ounces of water before taking

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

Other information

each tablet contains: sodium 567 mg
store at room temperature. Avoid excessive heat.
Alka-Seltzer® in water contains principally the antacid sodium citrate and the analgesic sodium acetylsalicylate

Inactive ingredients

None

Questions or comments?

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

Package Labeling

INGREDIENTS AND APPEARANCE

ALKA SELTZER ORIGINAL 
anhydrous citric acid, aspirin, sodium bicarbonate tablet, effervescent

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73097-001(NDC:0280-4000)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	1000 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM BICARBONATE	1916 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	25mm
Flavor		Imprint Code	ALKA;SELTZER
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73097-001-02	1 in 1 CARTON	07/01/2019
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 73097-001-40	20 in 1 CARTON	07/01/2019
2		2 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 73097-001-48	24 in 1 CARTON	07/01/2019
3		2 in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 73097-001-72	36 in 1 CARTON	07/01/2019
4		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	07/01/2019

Labeler - Savings Distributors LLC (010527359)