NDC 73097-001 Alka Seltzer Original

Product Information

Product Code73097-001
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Alka Seltzer Original
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Savings Distributors Llc
Labeler Code73097
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
07-01-2019
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2020
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
I
NDC Code Structure

Usage Information


Product Characteristics

Color(s)WHITE (C48325)
ShapeROUND (C48348)
Size(s)25 MM
Imprint(s)ALKA;SELTZER
Score1

Product Packages

NDC 73097-001-02

Package Description: 1 POUCH in 1 CARTON > 2 TABLET, EFFERVESCENT in 1 POUCH

NDC 73097-001-40

Package Description: 20 POUCH in 1 CARTON > 2 TABLET, EFFERVESCENT in 1 POUCH

NDC 73097-001-48

Package Description: 24 POUCH in 1 CARTON > 2 TABLET, EFFERVESCENT in 1 POUCH

NDC 73097-001-72

Package Description: 36 POUCH in 1 CARTON > 2 TABLET, EFFERVESCENT in 1 POUCH

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

Alka Seltzer Original is product labeled by Savings Distributors Llc. The product's dosage form is and is administered via form.


What are Alka Seltzer Original Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (Active Moiety)
  • ASPIRIN (UNII: R16CO5Y76E)
  • ASPIRIN (UNII: R16CO5Y76E) (Active Moiety)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • SODIUM CATION (UNII: LYR4M0NH37) (Active Moiety)


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:


Inactive Ingredient(s)

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)


* Please review the disclaimer below.

Alka Seltzer Original Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Active Ingredients (In Each Tablet)



Anhydrous citric acid 1000 mg

Aspirin 325 mg (NSAID)*

Sodium bicarbonate (heat-treated) 1916 mg

*nonsteroidal anti-inflammatory drug


Purposes



Antacid

Analgesic

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



• 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


Package Labeling




* Please review the disclaimer below.