FDA.reportPublic FDA data

Alka-Seltzer Plus

Manufacturer
Lil' Drug Store Products, Inc
Effective date
2022-09-01
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:54:34

Label at a glance#

ProductAlka-Seltzer Plus
Active ingredientASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE
Label structure9 sections

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

Dosage and administration

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

Storage and handling

each tablet contains: sodium 476 mg Phenylketonurics: Contains Phenylalanine 8.4 mg Per Tablet store at room temperature. Avoid excessive heat.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each tablet)Purposes
Aspirin 325 mg (NSAID) * Pain reliever/fever reducer
Chlorpheniramine maleate 2 mgAntihistamine
Phenylephrine bitartrate 7.8 mgNasal decongestant

* nonsteroidal anti-inflammatory drug

Uses

INDICATIONS & USAGE SECTION

  • 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

Warnings

WARNINGS SECTION

Reye's syndrome

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

Stomach bleeding warning

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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.

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

  • 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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking a prescription drug for
    • gout
    • diabetes
    • arthritis
  • taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • 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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: sodium 476 mg
  • Phenylketonurics: Contains Phenylalanine 8.4 mg Per Tablet
  • store at room temperature. Avoid excessive heat.

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, anhydrous citric acid, aspartame, calcium silicate, dimethicone, docusate sodium, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

Questions or comments?

OTC - QUESTIONS SECTION

1-800-986-0369 (Mon-Fri 9AM-5PM EST)

PRINCIPAL DISPLAY PANEL - 4 Tablet Pouch Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alka-
Seltzer
PLUS ®

Cold

SPARKLING
ORIGINAL

ASPIRIN (NSAID) / Pain Reliever-Fever Reducer
Chlorpheniramine Maleate / Antihistamine
Phenylephrine Bitartrate / Nasal Decongestant

  • Nasal Congestion
  • Runny Nose
  • Sore Throat
  • Headache &
    Body Ache
  • Sinus Pressure

4
Effervescent Tablets

Lil'
DrugStore ®

PRINCIPAL DISPLAY PANEL - 4 Tablet Pouch Carton
PRINCIPAL DISPLAY PANEL - 4 Tablet Pouch Carton

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-9735ALKA-SELTZER PLUS (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [LIL' DRUG STORE PRODUCTS, INC]5Legacy NDC20220903_cb87be72-e0c5-4491-85b5-b9b8d7d269cb.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AspirinACTIVE INGREDIENTR16CO5Y76E1
Chlorpheniramine MaleateACTIVE INGREDIENTV1Q0O9OJ9Z1
Phenylephrine BitartrateACTIVE INGREDIENT27O3Q5ML571
AspirinACTIVE MOIETYR16CO5Y76E1
ChlorpheniramineACTIVE MOIETY3U6IO1965U1
PhenylephrineACTIVE MOIETY1WS297W6MV1
Acesulfame PotassiumINACTIVE INGREDIENT23OV73Q5G91
Anhydrous Citric AcidINACTIVE INGREDIENTXF417D3PSL1
AspartameINACTIVE INGREDIENTZ0H242BBR11
Calcium SilicateINACTIVE INGREDIENTS4255P4G5M1
DimethiconeINACTIVE INGREDIENT92RU3N3Y1O1
Docusate SodiumINACTIVE INGREDIENTF05Q2T2JA01
MannitolINACTIVE INGREDIENT3OWL53L36A1
PovidonesINACTIVE INGREDIENTFZ989GH94E1
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EU1
Sodium BicarbonateINACTIVE INGREDIENT8MDF5V39QO1

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
66715-973566715-9735-1, 66715-9735-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM BICARBONATE8MDF5V39QOIACT
ACESULFAME POTASSIUM23OV73Q5G9IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
ASPARTAMEZ0H242BBR1IACT
CALCIUM SILICATES4255P4G5MIACT
DIMETHICONE92RU3N3Y1OIACT
DOCUSATE SODIUMF05Q2T2JA0IACT
MANNITOL3OWL53L36AIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SODIUM BENZOATEOJ245FE5EUIACT
ASPIRINR16CO5Y76EACTIB
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
PHENYLEPHRINE BITARTRATE27O3Q5ML57ACTIB

Source Document#

Source XML

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.

Inactive ingredient links page 1 of 5 · 278 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUSOLUTION / TOPICAL0.1 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLAEROSOL, FOAM / TOPICAL6 mgExact identifier — unii candidate
61 equally ranked IID candidates
Docusate SodiumDOCUSATE SODIUMF05Q2T2JA0TABLET / ORAL50 mgExact identifier — unii candidate
11 equally ranked IID candidates
MannitolMANNITOL3OWL53L36ASOLUTION / INTRAVENOUS15400 mgExact identifier — unii candidate
65 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINSERT / VAGINAL129 mgExact identifier — unii candidate
34 equally ranked IID candidates
MannitolMANNITOL3OWL53L36ATABLET, ORALLY DISINTEGRATING / SUBLINGUAL10.25 mgExact identifier — unii candidate
65 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / RESPIRATORY (INHALATION)5 mgExact identifier — unii candidate
61 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOGUM, CHEWING / BUCCAL240 mgExact identifier — unii candidate
34 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1TABLET, ORALLY DISINTEGRATING / ORAL180 mgExact identifier — unii candidate
19 equally ranked IID candidates
Docusate SodiumDOCUSATE SODIUMF05Q2T2JA0CAPSULE / ORAL8.2 mgExact identifier — unii candidate
11 equally ranked IID candidates
PovidonesPOVIDONEFZ989GH94ESOLUTION / OPHTHALMIC1.8 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
PovidonesPOVIDONEFZ989GH94ECAPSULE, EXTENDED RELEASE / ORAL56 mgExact identifier — unii candidate
30 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET, EXTENDED RELEASE / ORAL81 mgExact identifier — unii candidate
34 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
34 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL78 mgExact identifier — unii candidate
19 equally ranked IID candidates
Acesulfame PotassiumACESULFAME POTASSIUM23OV73Q5G9SOLUTION / ORAL400 mgExact identifier — unii candidate
17 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUFILM / BUCCAL1 mgExact identifier — unii candidate
35 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION, CONCENTRATE / INTRAVENOUS60 mgExact identifier — unii candidate
61 equally ranked IID candidates
PovidonesPOVIDONEFZ989GH94ETABLET, COATED / ORAL49.2 mgExact identifier — unii candidate
30 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / ORAL3900 mgExact identifier — unii candidate
61 equally ranked IID candidates
Acesulfame PotassiumACESULFAME POTASSIUM23OV73Q5G9TABLET, EFFERVESCENT / ORAL4 mgExact identifier — unii candidate
17 equally ranked IID candidates
MannitolMANNITOL3OWL53L36AINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS980.4 mgExact identifier — unii candidate
65 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLLIQUID / INTRAVENOUS18 mgExact identifier — unii candidate
61 equally ranked IID candidates
MannitolMANNITOL3OWL53L36AINJECTION / SUBCUTANEOUS675 mgExact identifier — unii candidate
65 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUCAPSULE / ORAL8.5 mgExact identifier — unii candidate
35 equally ranked IID candidates
MannitolMANNITOL3OWL53L36ASUSPENSION / OPHTHALMIC9 mgExact identifier — unii candidate
65 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET, ORALLY DISINTEGRATING / ORAL107 mgExact identifier — unii candidate
34 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, FOR SOLUTION / INTRAPERITONEALADJ PHExact identifier — unii candidate
34 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUCREAM / TOPICAL0.2 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
MannitolMANNITOL3OWL53L36ASPRAY / NASAL41.5 mgExact identifier — unii candidate
65 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET, DELAYED RELEASE / ORAL30 mgExact identifier — unii candidate
34 equally ranked IID candidates
MannitolMANNITOL3OWL53L36APOWDER / RESPIRATORY (INHALATION)6 mgExact identifier — unii candidate
65 equally ranked IID candidates
MannitolMANNITOL3OWL53L36ATABLET, CHEWABLE, EXTENDED RELEASE / ORAL616 mgExact identifier — unii candidate
65 equally ranked IID candidates
Acesulfame PotassiumACESULFAME POTASSIUM23OV73Q5G9POWDER, FOR SUSPENSION / ORAL45 mg/5mlExact identifier — unii candidate
17 equally ranked IID candidates
Docusate SodiumDOCUSATE SODIUMF05Q2T2JA0GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL20 mgExact identifier — unii candidate
11 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, SOLUTION / INTRAMUSCULAR25 mgExact identifier — unii candidate
61 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOPOWDER, FOR SOLUTION / ORAL1250 mg/100mlExact identifier — unii candidate
34 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLTABLET, CHEWABLE, EXTENDED RELEASE / ORAL12 mgExact identifier — unii candidate
61 equally ranked IID candidates
MannitolMANNITOL3OWL53L36ASOLUTION / OPHTHALMIC4.7 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
MannitolMANNITOL3OWL53L36ATABLET, CHEWABLE / ORAL3726 mgExact identifier — unii candidate
65 equally ranked IID candidates
MannitolMANNITOL3OWL53L36ASOLUTION / ORAL869 mgExact identifier — unii candidate
65 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLSPRAY / NASAL5 mgExact identifier — unii candidate
61 equally ranked IID candidates
MannitolMANNITOL3OWL53L36AINJECTION, SUSPENSION / INTRAVENOUS2.5 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
PovidonesPOVIDONEFZ989GH94ECAPSULE / ORAL300 mgExact identifier — unii candidate
30 equally ranked IID candidates
PovidonesPOVIDONEFZ989GH94EFILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii candidate
30 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / INTRAMUSCULAR101 mgExact identifier — unii candidate
61 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS81 mgExact identifier — unii candidate
61 equally ranked IID candidates
MannitolMANNITOL3OWL53L36AINJECTION, SOLUTION / SUBMUCOSAL2.94 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUGRANULE, EFFERVESCENT / ORAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
MannitolMANNITOL3OWL53L36AGUM, CHEWING / BUCCAL891 mgExact identifier — unii candidate
65 equally ranked IID candidates
MannitolMANNITOL3OWL53L36ASOLUTION / TOPICAL4 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUGRANULE, FOR SUSPENSION / ORAL120 mgExact identifier — unii candidate
35 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / TOPICAL4.35 %w/vExact identifier — unii candidate
61 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLCAPSULE / ORAL131 mgExact identifier — unii candidate
61 equally ranked IID candidates
Acesulfame PotassiumACESULFAME POTASSIUM23OV73Q5G9TABLET / ORAL111 mgExact identifier — unii candidate
17 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLTABLET / ORAL197 mgExact identifier — unii candidate
61 equally ranked IID candidates
MannitolMANNITOL3OWL53L36AGEL / OPHTHALMIC25 mgExact identifier — unii candidate
65 equally ranked IID candidates
MannitolMANNITOL3OWL53L36AINJECTION, SOLUTION / SUBCUTANEOUS99 mgExact identifier — unii candidate
65 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOFILM, SOLUBLE / ORAL2 mgExact identifier — unii candidate
34 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION/ DROPS / AURICULAR (OTIC)1 mgExact identifier — unii candidate
61 equally ranked IID candidates

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
e7a207e4-797f-08b4-e053-2a95a90af329cb87be72-e0c5-4491-85b5-b9b8d7d269cb2022-09-01WarningsExact identifier
spl id: e7a207e4-797f-08b4-e053-2a95a90af329
spl set id: cb87be72-e0c5-4491-85b5-b9b8d7d269cb

Reported adverse events (FAERS/openFDA)#

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