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 Bitterfeld GMBH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

• Active Ingredients: Purpose
• Anydrous citic acid 100mg: Antacid
• Aspirin 325 mg (NSAID)*: Analgesic
• Sodium bicarbonate (heat-treated) 1916 mg *nonsteroidal anti-inflammatory drug: Antacid

PURPOSE

Uses

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

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 cuase severe stomach bleeding. The chance is higher if you

• are age 60 or older
• have had stomach uclers or bleeding problems
• take a blood thinning (anticoagulant) or sterioid drug
• take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen naproxen, or others)
• have 3 or more alcoholic drinks every day while using the 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 diueretic
• 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 us. It is especially important not to use aspirin during the last 3 months of pregnancy unless defintely directed to do so by a doctor because it may cause problems in the unborn child or complicaitons 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 dissove 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

Other information

• each tablets 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 INGREDIENT

Inactive ingredients none

Questions or comments?

Questions or comments? 1-800-986-0369

(Mon-Fri 9AM - 5 PM EST)

PRINCIPAL DISPLAY PANEL

Alka-Seltzer® Original

Anhydrous citric acid / Antacid

Aspirin (NSAID) / Analgesic

Sodium bicarbonate / Antacid

Fast Relief of:

Heartburn

Upset Stomach

Acid Indigestion

with Headache

Body Aches

12 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: 65662-005
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
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)	SODIUM BICARBONATE	1916 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 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: 65662-005-01	6 in 1 CARTON	12/01/2008
1		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	12/01/2008

Labeler - Bayer Bitterfeld GMBH (330908898)