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

Alka-Seltzer by

Drug Labeling and Warnings

Alka-Seltzer by is a Otc medication manufactured, distributed, or labeled by Lil' Drug Store Products, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 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

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

PRINCIPAL DISPLAY PANEL - 2 Tablet Pouch Carton

See new warnings information

Alka-
Seltzer®

Anhydrous Citric Acid/Antacid
Aspirin (NSAID)/Analgesic
Sodium Bicarbonate/Antacid

FAST
RELIEF
OF:
Acid Indigestion
Upset Stomach
Heartburn with
Headache
Body Aches

ORIGINAL

2
EFFERVESCENT
TABLETS

Lil'
Drug Store®

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66715-9703
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	14mm
Flavor		Imprint Code	Alka;Seltzer
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66715-9703-1	1 in 1 CARTON	01/01/2000
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 66715-9703-2	2 in 1 CARTON	01/01/2000
2		2 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 66715-9703-0	15 in 1 CARTON	01/01/2000	12/31/2018
3		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	01/01/2000

Labeler - Lil' Drug Store Products, Inc (093103646)