Indications and uses
• temporarily relieves these symptoms due to a cold: • minor aches and pains • headache • runny nose • nasal and sinus congestion • sneezing • sore throat • temporarily reduces fever
• temporarily relieves these symptoms due to a cold: • minor aches and pains • headache • runny nose • nasal and sinus congestion • sneezing • sore throat • temporarily reduces fever
• adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 8 tablets in 24 hours or as directed by a doctor. • children under 12 years: do not use
Aspirin 325 mg (NSAID)*
Chlorpheniramine maleate 2 mg
Phenylephrine bitartrate 7.8 mg
*nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
Antihistamine
Nasal decongestant
• temporarily relieves these symptoms due to a cold:
• minor aches and pains • headache • runny nose • nasal and sinus congestion • sneezing • sore throat
• temporarily reduces fever
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.
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
Sore throat warning:If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use to sedate children.
• if you are allergic to aspirin or any other pain reliever/fever reducer
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
• if you have had a allergic reaction to this product or any of its ingredients
• in children under 12 years of age
• 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 • diabetes • thyroid disease • glaucoma •difficulty in urination due to enlargement of the prostate gland
• a breathing problem such as emphysema or chronic bronchitis • a sodium-restricted diet
• taking a prescription drug for
•gout • diabetes • arthritis
• taking sedatives or tranquilizers
• do not exceed recommended dosage
• excitability may occur, especially in children
• you may get drowsy
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• 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 or nasal congestion gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• ringing in the ears or a loss of hearing occurs
• nervousness, dizziness, or sleeplessness occurs
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.
In case of overdose, get medical help or contact a Poison Control Center right away.
• adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 8 tablets in 24 hours or as directed by a doctor.
• children under 12 years: do not use
• each tablet contains: sodium 474 mg
• Phenylketonurics: Contains Phenylalanine 8.4 mg Per Tablet
• store at room temperature. Avoid excessive heat.
acesulfame potassium, anhydrous citric acid, aspartame, calcium silicate, dimethylpolysiloxane, docusate sodium, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate
1-800-986-0369 (Mon - Fri 9AM - 5PM EST) or
www.alkaseltzerplus.com
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1536840 | aspirin 325 MG / chlorpheniramine maleate 2 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | PSN | 1 |
| 1536840 | aspirin 325 MG / chlorpheniramine maleate 2 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SCD | 1 |
| 1536840 | ASA 325 MG / Chlorpheniramine Maleate 2 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SY | 1 |
| Class | Version | Type | Effective |
|---|---|---|---|
| ASPIRIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20191108 |
| CHLORPHENIRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 73097-002-02 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-45b1-a910-e053-dadaa90a0b85 | Alka Seltzer Plus Cold |
| 73097-002-40 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-45b1-a910-e053-dadaa90a0b85 | Alka Seltzer Plus Cold |
| 73097-002-48 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-45b1-a910-e053-dadaa90a0b85 | Alka Seltzer Plus Cold |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 73097-002-02 | Alka Seltzer Plus Cold | 1 in 1 CARTON | TABLET, EFFERVESCENT | 1 | 1 | |
| 73097-002-02 | Alka Seltzer Plus Cold | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 1 | |
| 73097-002-40 | Alka Seltzer Plus Cold | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 1 | |
| 73097-002-40 | Alka Seltzer Plus Cold | 20 in 1 CARTON | TABLET, EFFERVESCENT | 20 | 1 | |
| 73097-002-48 | Alka Seltzer Plus Cold | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 1 | |
| 73097-002-48 | Alka Seltzer Plus Cold | 24 in 1 CARTON | TABLET, EFFERVESCENT | 24 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 73097-002 | ALKA SELTZER PLUS COLD (ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [SAVINGS DISTRIBUTORS LLC] | 1 | Legacy NDC, 6 package rows | 20190710_8d44240f-e92c-19ac-e053-2a95a90ad73d.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0280-1520-20 | EA - Each | 0280-1520 | 6158b87c-7a87-4ba4-a68a-8c8030851d1d | 1 | 2022-06-06 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 73097-002 | 73097-002-02, 73097-002-40, 73097-002-48 |
| 0280-1520 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACESULFAME POTASSIUM | 23OV73Q5G9 | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| ASPARTAME | Z0H242BBR1 | IACT |
| CALCIUM SILICATE | S4255P4G5M | IACT |
| DIMETHICONE | 92RU3N3Y1O | IACT |
| DOCUSATE SODIUM | F05Q2T2JA0 | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| POVIDONE | FZ989GH94E | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM BICARBONATE | 8MDF5V39QO | IACT |
| ASPIRIN | R16CO5Y76E | ACTIB |
| CHLORPHENIRAMINE MALEATE | V1Q0O9OJ9Z | ACTIB |
| PHENYLEPHRINE BITARTRATE | 27O3Q5ML57 | ACTIB |
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 Plus Cold Sparkling Original | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | 531ab703-179a-70ad-e054-00144ff88e88 | 2025-12-04 | Warnings | 0280-1520 |
| 8d43e50a-6318-9948-e053-2995a90a4f14 | 8d44240f-e92c-19ac-e053-2a95a90ad73d | 2019-07-09 | Warnings | 8d43e50a-6318-9948-e053-2995a90a4f14 8d44240f-e92c-19ac-e053-2a95a90ad73d |
Adverse event summaries are temporarily unavailable. Other product information remains available.