Alka-Seltzer Plus® Multi-Symptom Cold Night Effervescent Tablets
- Manufacturer
- Bayer HealthCare LLC.
- Effective date
- 2018-10-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:49:23
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
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
OTC - PURPOSE SECTION
Purposes
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
INDICATIONS & USAGE SECTION
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 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
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.
OTC - DO NOT USE SECTION
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
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 ● 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
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
● taking a prescription drug for
● gout ● diabetes ● arthritis
● taking sedatives or tranquilizers
OTC - WHEN USING SECTION
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
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, 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
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 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.
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
● 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 SAFETY INFORMATION
Other information
● each tablet contains: sodium 476 mg
● Phenylketonurics: Contains Phenylalanine 5.6 mg Per Tablet
● store at room temperature. Avoid excessive heat.
INACTIVE INGREDIENT SECTION
Inactive ingredients acesulfame potassium, anhydrous citric acid, aspartame, calcium silicate, dimethicone, docusate sodium, flavors (natural & artificial), mannitol, povidone, sodium benzoate, sodium bicarbonate
OTC - QUESTIONS SECTION
Questions or comments? 1-800-986-0369 (Mon-Fri 9AM - 5PM EST)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Products#
Every source-derived product name is available through these pages.
- Alka-Seltzer Plus Multi-Symptom Cold Night
- Aspirin, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine bitartrate
- ASPIRIN
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- CALCIUM SILICATE
- SODIUM BICARBONATE
- SODIUM BENZOATE
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE BITARTRATE
- PHENYLEPHRINE
- ACESULFAME POTASSIUM
- ANHYDROUS CITRIC ACID
- DIMETHICONE
- DOCUSATE SODIUM
- MANNITOL
- POVIDONE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0280-1541 | 0280-1541-20 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ASPIRIN | R16CO5Y76E | ACTIB |
| DOXYLAMINE SUCCINATE | V9BI9B5YI2 | ACTIB |
| CALCIUM SILICATE | S4255P4G5M | IACT |
| SODIUM BICARBONATE | 8MDF5V39QO | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| PHENYLEPHRINE BITARTRATE | 27O3Q5ML57 | ACTIB |
| ACESULFAME POTASSIUM | 23OV73Q5G9 | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| DIMETHICONE | 92RU3N3Y1O | IACT |
| DOCUSATE SODIUM | F05Q2T2JA0 | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| POVIDONE | FZ989GH94E | IACT |
Source Document#
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 |
|---|---|---|---|---|---|---|
| 77cfe122-d13d-06f5-e053-2991aa0a5f94 | 540f375c-99e6-4444-e054-00144ff8d46c | 2018-10-09 | Warnings | 77cfe122-d13d-06f5-e053-2991aa0a5f94 540f375c-99e6-4444-e054-00144ff8d46c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
