ALKA-SELTZER EXTRA STRENGTH- anhydrous citric acid, sodium bicarbonate, and aspirin granule, effervescent

Alka-Seltzer Extra Strength by

Drug Labeling and Warnings

Alka-Seltzer Extra Strength by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each tablet)	Purpose
Anhydrous citric acid 1000 mg	Antacid
Aspirin 500 mg	Analgesic
Sodium bicarbonate (heat-treated) 1985 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 anticoagulation (blood thinning), 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 6 hours, or as directed by a doctor	do not exceed 7 tablets in 24 hours
adults 60 years and over	2 tablets every 6 hours, or as directed by a doctor	do not exceed 3 tablets in 24 hours
children under 12 years	consult a doctor

Other information

• each tablet contains: sodium 588 mg
• store at room temperature. Avoid excessive heat.
• Alka-Seltzer Extra Strength in water contains principally the antacid sodium citrate and the analgesic sodium acetylsalicylate

Inactive ingredients

flavor

Questions or comments?

1-800-986-0369 (Mon - Fri 9AM - 5PM EST)

PRINCIPAL DISPLAY PANEL - 24 Tablets Carton

Alka-

Seltzer ®

ANTACID & PAIN RELIEF MEDICINE

FAST

RELIEF

OF:

Acid Indigestion

Upset Stomach

Heartburn with

Headache

Body Aches

XTRA

STRENGTH

24 EFFERVESCENT TABLETS

INGREDIENTS AND APPEARANCE

ALKA-SELTZER EXTRA STRENGTH 
anhydrous citric acid, sodium bicarbonate, and aspirin granule, effervescent

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0280-0211
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) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM BICARBONATE	1985 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	500 mg

Inactive Ingredients
Ingredient Name	Strength
LEMON (UNII: 24RS0A988O)

Product Characteristics
Color	white (White tablet)	Score	no score
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: 0280-0211-24	12 in 1 CARTON	04/18/2011
1		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 not final	part343	04/11/2011

Labeler - Bayer HealthCare LLC. (112117283)