Alka-Seltzer Original Flavor
- Manufacturer
- Bayer HealthCare LLC.
- Effective date
- 2025-12-04
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 10
- Source
- full-release
- Hydrated at
- 2026-06-01 01:19:36
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet)
Buffered aspirin 325 mg (NSAID)*
OTC - PURPOSE SECTION
Pain reliever/fever reducer
*nonsteroidal anti-inflammatory drug
INDICATIONS & USAGE SECTION
Uses
● temporarily relieves minor aches and pains due to:
● headache ● muscle pain ● backache
● toothache ● menstrual pain ● colds
● minor pain of arthritis
● temporarily reduces fever
WARNINGS SECTION
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
OTC - DO NOT USE SECTION
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
OTC - ASK DOCTOR SECTION
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
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking a prescription drug for
● diabetes ● gout ● arthritis
OTC - STOP USE SECTION
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
● pain gets worse or last more than 10 days
● fever gets worse or last more than 3 days
● redness or swelling is present
● new symptoms occur
● ringing in the ears or a loss of hearing occurs
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
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 SAFETY INFORMATION
Other information
● each tablet contains: sodium 568 mg
● store at room temperature. Avoid excessive heat.
● Alka-Seltzer Original Flavor in water contains principally the analgesic sodium acetylsalicylate
INACTIVE INGREDIENT SECTION
Inactive Ingredients anhydrous citric acid, sodium bicarbonate
OTC - QUESTIONS SECTION
Questions or comments?1-800-986-0369 (Mon – Fri 9AM – 5PM EST)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Alka-Seltzer
Buffered Aspirin (NSAID) / Pain reliever / fever reducer
Fast Relief of:
Headache
Backache
Body Aches
Muscle Pain
ORIGINAL FLAVOR
24 EFFERVESCENT TABLETS
(12 - 2 count pouches)
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ASPIRIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20191108 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0280-0087-01 | Alka-Seltzer Original Flavor | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 10 | |
| 0280-0087-01 | Alka-Seltzer Original Flavor | 6 in 1 CARTON | TABLET, EFFERVESCENT | 6 | 10 | |
| 0280-0087-02 | Alka-Seltzer Original Flavor | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 10 | |
| 0280-0087-02 | Alka-Seltzer Original Flavor | 18 in 1 CARTON | TABLET, EFFERVESCENT | 18 | 10 | |
| 0280-0087-03 | Alka-Seltzer Original Flavor | 36 in 1 CARTON | TABLET, EFFERVESCENT | 36 | 10 | |
| 0280-0087-03 | Alka-Seltzer Original Flavor | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 10 | |
| 0280-0087-04 | Alka-Seltzer Original Flavor | 12 in 1 CARTON | TABLET, EFFERVESCENT | 12 | 10 | |
| 0280-0087-04 | Alka-Seltzer Original Flavor | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 10 | |
| 0280-0087-06 | Alka-Seltzer Original Flavor | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 10 | |
| 0280-0087-06 | Alka-Seltzer Original Flavor | 58 in 1 CARTON | TABLET, EFFERVESCENT | 58 | 10 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ANHYDROUS CITRIC ACID | ACTIVE INGREDIENT | XF417D3PSL | 1 | |
| ASPIRIN | ACTIVE INGREDIENT | R16CO5Y76E | 1 | |
| SODIUM BICARBONATE | ACTIVE INGREDIENT | 8MDF5V39QO | 1 | |
| ANHYDROUS CITRIC ACID | ACTIVE MOIETY | XF417D3PSL | 1 | |
| ASPIRIN | ACTIVE MOIETY | R16CO5Y76E | 1 | |
| SODIUM CATION | ACTIVE MOIETY | LYR4M0NH37 | 1 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | 1 | |
| DOCUSATE SODIUM | INACTIVE INGREDIENT | F05Q2T2JA0 | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | 1 | |
| sodium benzoate | INACTIVE INGREDIENT | OJ245FE5EU | 1 |
Products#
Every source-derived product name is available through these pages.
- Alka-Seltzer Original Flavor
- ANHYDROUS CITRIC ACID
- SODIUM BICARBONATE
- ASPIRIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0280-0087 | 0280-0087-04, 0280-0087-02, 0280-0087-03, 0280-0087-01, 0280-0087-06 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| SODIUM BICARBONATE | 8MDF5V39QO | IACT |
| ASPIRIN | R16CO5Y76E | ACTIB |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, ORALLY DISINTEGRATING / ORAL | 15.03 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET / ORAL | 216 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | POWDER, FOR SUSPENSION / ORAL | 420 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | LOZENGE / ORAL | 136 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | POWDER, FOR SOLUTION / ORAL | 233 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 78 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | SYRUP / ORAL | 0.63 mg/5ml | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET, FOR SUSPENSION / ORAL | 15 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | GRANULE, FOR SUSPENSION / ORAL | 420 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 18 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | SOLUTION / ORAL | 3000 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | GRANULE, EFFERVESCENT / ORAL | 30 mg | ||
| sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION/ DROPS / ORAL | 23 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, FOR SUSPENSION / ORAL | 2 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | DROPS / ORAL | NA | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE / ORAL | 300 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE, DELAYED RELEASE / ORAL | NA | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 17 mg | ||
| sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | TABLET, DELAYED RELEASE / ORAL | 0.34 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 78 mg | ||
| DOCUSATE SODIUM | DOCUSATE SODIUM | F05Q2T2JA0 | TABLET, COATED / ORAL | 1 mg | ||
| sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | SOLUTION / ORAL | 660 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE, COATED PELLETS / ORAL | 10.03 mg | ||
| sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | TABLET, COATED / ORAL | 0.2 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TROCHE / ORAL | 30 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, CHEWABLE / ORAL | 48 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 17 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE / ORAL | 300 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | POWDER, FOR SOLUTION / ORAL | 233 mg | ||
| DOCUSATE SODIUM | DOCUSATE SODIUM | F05Q2T2JA0 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 20 mg | ||
| sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION/ DROPS / ORAL | 23 mg | ||
| sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | TABLET, EXTENDED RELEASE / ORAL | NA | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 32 mg | ||
| DOCUSATE SODIUM | DOCUSATE SODIUM | F05Q2T2JA0 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 20 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | SUSPENSION / ORAL | 20 mg/5ml | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | CAPSULE, EXTENDED RELEASE / ORAL | 3 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET / ORAL | 216 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET, ORALLY DISINTEGRATING / ORAL | 180 mg | ||
| sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | POWDER, FOR SOLUTION / ORAL | 98 mg | ||
| DOCUSATE SODIUM | DOCUSATE SODIUM | F05Q2T2JA0 | TABLET, FILM COATED / ORAL | 6 mg | ||
| sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | ELIXIR / ORAL | 5.02 mg/5ml | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET, FILM COATED / ORAL | 20 mg | ||
| sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | TABLET / ORAL | 30 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE, EXTENDED RELEASE / ORAL | 56 mg | ||
| sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION, EXTENDED RELEASE / ORAL | 24 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET, FILM COATED / ORAL | 20 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE, COATED PELLETS / ORAL | 10.03 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, DELAYED RELEASE / ORAL | 53 mg | ||
| DOCUSATE SODIUM | DOCUSATE SODIUM | F05Q2T2JA0 | SUSPENSION, EXTENDED RELEASE / ORAL | 0.77 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | SUSPENSION / ORAL | 23 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | GRANULE, FOR SUSPENSION / ORAL | 420 mg | ||
| sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | SYRUP / ORAL | 80 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE, DELAYED RELEASE / ORAL | NA | ||
| sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | TABLET, DELAYED RELEASE / ORAL | 0.34 mg | ||
| sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | ELIXIR / ORAL | 5.02 mg/5ml | ||
| sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | POWDER, FOR SUSPENSION / ORAL | 160 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | LOZENGE / ORAL | 136 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | POWDER / ORAL | 63 mg |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Alka-Seltzer Original Flavor | ALKA-SELTZER ORIGINAL FLAVOR | Bayer HealthCare LLC. | 07478020-5ba0-3b67-e054-00144ff88e88 | 2025-12-04 | Warnings | 0280-0087-01 0280-0087-04 0280-0087-02 0280-0087-06 0280-0087-03 0280-0087 00280008704 00280008701 00280008703 00280008702 00280008706 452648e2-82a6-84f5-e063-6394a90a6df1 07478020-5ba0-3b67-e054-00144ff88e88 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
