ALKA-SELTZER ORIGINAL- anhydrous citric acid, aspirin, and 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 Bayer HealthCare LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each tablet)	Purpose
* nonsteroidal anti-inflammatory drug
Anhydrous citric acid 1000 mg	Antacid
Aspirin 325 mg (NSAID) *	Analgesic
Sodium bicarbonate (heat-treated) 1916 mg	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

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)

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Dist. by: Bayer HealthCare LLC
Whippany, NJ 07981

PRINCIPAL DISPLAY PANEL - 24 Tablet Carton

Alka-

Seltzer ®

Anhydrous citric acid / Antacid

Aspirin ( NSAID) / Analgesic

Sodium bicarbonate / Antacid

Fast Relief of:

Heartburn

Upset Stomach

Acid Indigestion

with Headache

Body Aches

ORIGINAL

24 EFFERVESCENT TABLETS

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	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) (BICARBONATE ION - UNII:HN1ZRA3Q20)	SODIUM BICARBONATE	1916 mg

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: 0280-4000-01	6 in 1 CARTON	10/10/2012
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 0280-4000-02	24 in 1 CARTON	10/10/2012
2		2 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 0280-4000-03	18 in 1 CARTON	10/10/2012
3		2 in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 0280-4000-07	26 in 1 CARTON	10/10/2012
4		2 in 1 POUCH; Type 0: Not a Combination Product
5	NDC: 0280-4000-04	58 in 1 CARTON	10/10/2012
5		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	03/02/2010

Labeler - Bayer HealthCare LLC. (112117283)