Indications and uses
Uses ● temporarily relieves these symptoms due to a cold: ● minor aches and pains ● headache ● runny nose ● sinus congestion and pressure ● cough ● sneezing ● sore throat ● nasal congestion ● temporarily reduces fever
Uses ● temporarily relieves these symptoms due to a cold: ● minor aches and pains ● headache ● runny nose ● sinus congestion and pressure ● cough ● sneezing ● sore throat ● nasal congestion ● temporarily reduces fever
Directions ● adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water at bedtime (may be taken every 4 to 6 hours). Do not exceed 8 tablets in 24 hours or as directed by a doctor. ● children under 12 years: do not use
Drug Facts
Active ingredients (in each tablet)
Aspirin 500 mg (NSAID)*
Dextromethorphan hydrobromide 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine bitartrate 7.8 mg
*nonsteroidal anti-inflammatory drug
Purposes
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
Uses
● temporarily relieves these symptoms due to a cold:
● minor aches and pains ● headache ● runny nose
● sinus congestion and pressure ● cough ● sneezing
● sore throat ● nasal congestion
● temporarily reduces fever
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
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.
Do not use
● 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 ever had an allergic reaction to this product or any of its
ingredients
● in children under 12 years of age
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 ● diabetes ● thyroid disease ● glaucoma
● cough with excessive phlegm (mucus)
● a breathing problem such as emphysema or chronic bronchitis
● difficulty in urination due to enlargement of the prostate gland
● persistent or chronic cough such as occurs with smoking, asthma,
or emphysema
● a sodium-restricted diet
Ask a doctor or pharmacist before use if you are
● taking a prescription drug for
● gout ● diabetes ● arthritis
● taking sedatives or tranquilizers
When using this product
● do not exceed recommended dosage
● may cause marked drowsiness
● avoid alcoholic drinks
● alcohol, sedatives, and tranquilizers may increase drowsiness
● be careful when driving a motor vehicle or operating machinery
● excitability may occur, especially in children
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, cough, 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
● cough comes back or occurs with rash or headache that lasts. These
could be signs of a serious condition.
● 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.
Keep out of reach of children. In case of overdose, get medical help
or contact a Poison Control Center right away
Directions
● adults and children 12 years and over: take 2 tablets fully dissolved
in 4 oz of water at bedtime (may be taken every 4 to 6 hours). Do not
exceed 8 tablets in 24 hours or as directed by a doctor.
● children under 12 years: do not use
Other information
● each tablet contains: sodium 476 mg
● Phenylketonurics: Contains Phenylalanine 5.6 mg Per Tablet
● store at room temperature. Avoid excessive heat.
Inactive ingredients acesulfame potassium, anhydrous citric
acid, aspartame, calcium silicate, dimethicone, docusate sodium,
flavors (natural & artificial), mannitol, povidone, sodium benzoate,
sodium bicarbonate
Questions or comments?1-800-986-0369 (Mon-Fri 9AM -
5PM EST)
Alka-Seltzer
Plus ®
Cold
Night
Lemon
ASPIRIN ( NSAID) / Pain Reliever-Fever Reducer
Dextromethorphan HBr / Cough Suppressant
Doxylamine Succinate / Antihistamine
Phenylephrine Bitartrate / Nasal Decongestant
20 EFFERVESCENT TABLETS
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1536503 | aspirin 500 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | PSN | 6 |
| 1536503 | aspirin 500 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SCD | 6 |
| 1536503 | ASA 500 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SY | 6 |
| Class | Version | Type | Effective |
|---|---|---|---|
| ASPIRIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20191108 |
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| DOXYLAMINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0280-1545-20 | Alka-Seltzer Plus Cold Night | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 6 | |
| 0280-1545-20 | Alka-Seltzer Plus Cold Night | 10 in 1 CARTON | TABLET, EFFERVESCENT | 10 | 6 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0280-1545-20 | EA - Each | 0280-1545 | f9b5da63-1386-4d16-a784-ded8eefd8c79 | 1 | 2022-06-06 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0280-1545 | 0280-1545-20 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DIMETHICONE | 92RU3N3Y1O | IACT |
| DOCUSATE SODIUM | F05Q2T2JA0 | IACT |
| ASPIRIN | R16CO5Y76E | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| DOXYLAMINE SUCCINATE | V9BI9B5YI2 | ACTIB |
| PHENYLEPHRINE BITARTRATE | 27O3Q5ML57 | ACTIB |
| ACESULFAME POTASSIUM | 23OV73Q5G9 | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| ASPARTAME | Z0H242BBR1 | IACT |
| CALCIUM SILICATE | S4255P4G5M | IACT |
| POVIDONE | FZ989GH94E | IACT |
| SODIUM BICARBONATE | 8MDF5V39QO | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
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 Night | ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | 7588ea67-68a9-4dc0-e053-2991aa0aa471 | 2025-12-04 | Warnings | 0280-1545-20 0280-1545 00280154520 45267736-ecae-d911-e063-6294a90a98bc 7588ea67-68a9-4dc0-e053-2991aa0aa471 |
Adverse event summaries are temporarily unavailable. Other product information remains available.