ALKA-SELTZER- aspirin, citric acid, sodium bicarbonate effervescent tablet 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]

Pouch Header

Alka-Seltzer ®

Anhydrous citric acid / Antacid

Aspirin ( NSAID) / Analgesic

Sodium bicarbonate / Antacid

[Bayer logo]

ORIGINAL Fast Relief

Do not use if pouch is torn or open

2 EFFERVESCENT TABLETS

ACTIVE INGREDIENT

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

*nonsteroidal anti-inflammatory drug

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

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

Allergy alert: Aspirin may cause a severe allergic reaction which may
include:

hives

facial swelling

asthma (wheezing)

shock

Stomach bleeding warning

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: take 2 tablets every 4 hours,or as directed by a doctor. Do not exceed 8 tablets in 24 hours. Adults 60 years and over: take 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

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

Bayer HealthCare LLC, P.O. Box 1910, Morristown, NJ 07962-1910

PRINCIPAL DISPLAY PANEL

Alka-

Seltzer ®

Anhydrous citric acid / Antacid

Aspirin (NSAID) / Analgesic

Sodium bicarbonate / Antacid

[Bayer logo]

ORIGINAL

15 PACKETS OF

2 EFFERVESCENT TABLETS

www.lildrugstore.com

[UPC]

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66715-5106
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: 66715-5106-0	15 in 1 BOX, UNIT-DOSE	01/17/2008	06/01/2026
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 Drug	M001	01/17/2008	06/01/2026

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