FDA.reportPublic FDA data

ALKA SELTZER COLD Cold & Congestion Severe Night Fast Dissolve UI 1614459

Manufacturer
Bayer HealthCare LLC.
Effective date
2026-04-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-06-03 18:04:05

Label at a glance#

ProductAlka Seltzer Cold Cold and Congestion Severe Night Fast Dissolve
Active ingredientASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE
Label structure9 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each tablet) Purposes

Aspirin 325 mg (NSAID)*….………………….Pain reliever/fever reducer

Chlorpheniramine maleate 2 mg……………….………...…Antihistamine

Dextromethorphan hydrobromide 10 mg……………Cough suppressant

Phenylephrine bitartrate 7.8 mg.......…………….….Nasal decongestant

*nonsteroidal anti-inflammatory drug

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 that is accompanied by excessive phlegm (mucus)
      • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
      • a breathing problem such as emphysema or chronic bronchitis
      • difficulty in urination due to enlargement of the prostate gland
      • 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, or arthritis
  • taking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product

  • do not exceed recommended dosage
  • may cause marked drowsiness
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • 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
  • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
  • ringing in the ears or a loss of hearing occurs
  • 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 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

● 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 of age: do not use

OTHER SAFETY INFORMATION

Other information
● each tablet contains: potassium 80 mg; sodium 356 mg
● store between 20 oC to 25 oC (68 oF to 77 oF). Avoid excessive heat above 40 oC (104 oF).

INACTIVE INGREDIENT SECTION

Inactive ingredients anhydrous citric acid, calcium silicate, dimethicone, flavors, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose

OTC - QUESTIONS SECTION

Questions or comments? 1-800-986-0369 (Mon-Fri 8AM - 8PM EST)

Carton 24 count

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130016500598862GTIN-13: 0016500598862
EAN-13: 0016500598862
GTIN-12: 016500598862
UPC-A: 016500598862
GTIN storage (14 digits): 00016500598862		ASC Cold and Congestion Fast Dissolve 24 ct.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0280-82650280-8265-24, 0280-8265-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM BICARBONATE8MDF5V39QOIACT
ASPIRINR16CO5Y76EACTIB
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE BITARTRATE27O3Q5ML57ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CALCIUM SILICATES4255P4G5MIACT
DIMETHICONE92RU3N3Y1OIACT
MANNITOL3OWL53L36AIACT
POTASSIUM BICARBONATEHM5Z15LEBNIACT
POVIDONEFZ989GH94EIACT
SUCRALOSE96K6UQ3ZD4IACT

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alka Seltzer Cold Cold and Congestion Severe Night Fast DissolveASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.4f0c1b8e-3fb1-ccf2-e063-6394a90acd152026-04-09WarningsExact identifier
ndc (package): 0280-8265-16
ndc (package): 0280-8265-24
ndc (product): 0280-8265
ndc11 (package): 00280826524
ndc11 (package): 00280826516
spl id: 4f0c1b8e-3fb0-ccf2-e063-6394a90acd15
spl set id: 4f0c1b8e-3fb1-ccf2-e063-6394a90acd15

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.