Label: ALKA-SELTZER ORIGINAL- Anhydrous Citric Acid, Aspirin ...

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

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• NDC Code(s): 0280-4000-01, 0280-4000-02, 0280-4000-03, 0280-4000-04, view more 0280-4000-05, 0280-4000-06, 0280-4000-07
• Packager: Bayer HealthCare LLC.

• Category: HUMAN OTC DRUG LABEL
• DEA Schedule: None

Drug Label Information

Updated December 4, 2025

If you are a consumer or patient please visit this version.

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• 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 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

  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)

• SPL UNCLASSIFIED SECTION

  Dist. by: Bayer HealthCare LLC Whippany, NJ 07981

• PRINCIPAL DISPLAY PANEL - 24 Tablet Carton

  Alka- Seltzer ®

  Anhydrous citric acid / Antacid Aspirin ( NSAID) / Analgesic Sodium bicarbonate / Antacid

  Fast Relief of: Heartburn Upset Stomach Acid Indigestion with Headache Body Aches

  ORIGINAL

  24 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:0280-4000 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:0280-4000-01 6 in 1 CARTON 10/10/2012 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:0280-4000-02 24 in 1 CARTON 10/10/2012 2 2 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:0280-4000-03 18 in 1 CARTON 10/10/2012 3 2 in 1 POUCH; Type 0: Not a Combination Product 4 NDC:0280-4000-07 26 in 1 CARTON 10/10/2012 4 2 in 1 POUCH; Type 0: Not a Combination Product 5 NDC:0280-4000-04 58 in 1 CARTON 10/10/2012 5 2 in 1 POUCH; Type 0: Not a Combination Product 6 NDC:0280-4000-05 36 in 1 CARTON 10/10/2012 6 2 in 1 POUCH; Type 0: Not a Combination Product 7 NDC:0280-4000-06 12 in 1 CARTON 03/24/2022 7 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 M013 03/02/2010

  Labeler - Bayer HealthCare LLC. (112117283)

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

Number of versions: 10

Published Date (What is this?)	Version	Files
Dec 5, 2025	11 (current)	download
Dec 5, 2023	10	download
Apr 6, 2022	9	download
Mar 16, 2022	8	download
Feb 21, 2022	7	download
Jan 13, 2021	6	download
Nov 19, 2019	5	download
Jul 24, 2017	4	download
Aug 31, 2016	3	download
Dec 10, 2014	2	download

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

RxCUI	RxNorm NAME	RxTTY
1	1536675	aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG Effervescent Oral Tablet	PSN
2	1536675	aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG Effervescent Oral Tablet	SCD
3	1536675	ASA 325 MG / Citric Acid 1000 MG / NaHCO3 1916 MG Effervescent Oral Tablet	SY
4	1536680	Alka-Seltzer 325 MG / 1000 MG / 1916 MG Effervescent Oral Tablet	PSN
5	1536680	aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG Effervescent Oral Tablet [Alka-Seltzer]	SBD
6	1536680	Alka-Seltzer (aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG) Effervescent Oral Tablet	SY
7	1536680	ASA 325 MG / Citric Acid 1000 MG / NaHCO3 1916 MG Effervescent Oral Tablet [Alka-Seltzer]	SY

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

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

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.

NDC
1	0280-4000-01
2	0280-4000-02
3	0280-4000-03
4	0280-4000-04
5	0280-4000-05
6	0280-4000-06
7	0280-4000-07

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