Alka-Seltzer Plus Severe Sinus Cold and Cough

Manufacturer
Bayer HealthCare LLC. | Bayer HealthCare LLC Consumer Care
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:20:12

Label at a glance#

ProductAlka-Seltzer Plus Severe Sinus Cold and Cough Liquid Gels
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure15 sections

Indications and uses

temporarily relieves these symptoms due to a cold: · nasal congestion · sinus congestion and pressure · headache · minor aches and pains · cough · sore throat temporarily restores freer breathing through the nose helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily reduces fever

Dosage and administration

do not take more than the recommended dose adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 12 capsules in 24 hours or as directed by a doctor. children under 12 years: do not use

Label contents#

Full prescribing information#

Active ingredients (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each capsule)Purposes
Acetaminophen 250 mgPain reliever/fever reducer
Dextromethorphan hydrobromide 10 mgCough suppressant
Guaifenesin 200 mgExpectorant
Phenylephrine hydrochloride 5 mgNasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms due to a cold:

· nasal congestion

· sinus congestion and pressure

· headache

· minor aches and pains

· cough

· sore throat

  • temporarily restores freer breathing through the nose
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 12 capsules in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy Alert: acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash
  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

If a skin or general allergic reaction occurs, stop use and seek medical help right away.

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

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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 you have

OTC - ACTIVE INGREDIENT SECTION

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough with excessive phlegm (mucus)

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

OTC - WHEN USING SECTION

When using this product do not exceed recommended dosage

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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 fever, 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.

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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than the recommended dose
  • adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 12 capsules in 24 hours or as directed by a doctor.
  • children under 12 years: do not use

Other information

OTHER SAFETY INFORMATION

  • store at 15-25ºC (59-77ºF)

INACTIVE INGREDIENT SECTION

FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol-sorbitan solution, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments? 1-800-986-0369 (Mon-Fri 9AM - 5PM EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDPPDPPDPPDPPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1432488acetaminophen 250 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral CapsulePSN8
1432488acetaminophen 250 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD8
1432488APAP 250 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSY8

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-0507-20Alka-Seltzer Plus Severe Sinus Cold and CoughLiquid Gels2 in 1 CARTONCAPSULE, LIQUID FILLED28
0280-0507-20Alka-Seltzer Plus Severe Sinus Cold and CoughLiquid Gels20 in 1 BLISTER PACKCAPSULE, LIQUID FILLED208

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0280-0507-20EA - Each0280-050799c5c10e-b66c-485b-a516-479f2e13041212019-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYH1
GUAIFENESINACTIVE INGREDIENT495W7451VQ1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJ1
ACETAMINOPHENACTIVE MOIETY362O9ITL9D1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTS1
GUAIFENESINACTIVE MOIETY495W7451VQ1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MV1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA1
GELATININACTIVE INGREDIENT2G86QN327L1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A1
POVIDONESINACTIVE INGREDIENTFZ989GH94E1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
SHELLACINACTIVE INGREDIENT46N107B71O1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0280-05070280-0507-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

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 2 · 116 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SHELLACSHELLAC46N107B71OTABLET, FILM COATED / ORAL4.4 mgExact identifier — unii+route
24 equally ranked IID candidates
SHELLACSHELLAC46N107B71OTABLET, EXTENDED RELEASE / ORAL213.24 mgExact identifier — unii+route
24 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ECAPSULE, COATED PELLETS / ORAL10.03 mgExact identifier — unii+route
42 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii+route
40 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, FILM COATED / ORAL240 mgExact identifier — unii+route
42 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3ELIXIR / ORAL9306 mgExact identifier — unii+route
40 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, COATED / ORAL49.2 mgExact identifier — unii+route
42 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ESUSPENSION / ORAL20 mg/5mlExact identifier — unii+route
42 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii+route
40 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETROCHE / ORAL30 mgExact identifier — unii+route
42 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, FILM COATED, EXTENDED RELEASE / ORAL17 mgExact identifier — unii+route
42 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ECAPSULE / ORAL300 mgExact identifier — unii+route
42 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ESOLUTION / ORAL3000 mgExact identifier — unii+route
42 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, EXTENDED RELEASE / ORAL101 mgExact identifier — unii+route
42 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, ORALLY DISINTEGRATING / ORAL15.03 mgExact identifier — unii+route
42 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETROCHE / ORAL30 mgExact identifier — unii+route
42 equally ranked IID candidates
SHELLACSHELLAC46N107B71OTABLET, DELAYED RELEASE / ORAL8 mgExact identifier — unii+route
24 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED, EXTENDED RELEASE / ORAL19 mgExact identifier — unii+route
40 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, COATED / ORAL49.2 mgExact identifier — unii+route
42 equally ranked IID candidates
SHELLACSHELLAC46N107B71OTABLET, FILM COATED / ORAL4.4 mgExact identifier — unii+route
24 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii+route
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED / ORAL25 mgExact identifier — unii+route
40 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, LIQUID FILLED / ORAL1 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, CHEWABLE / ORAL48 mgExact identifier — unii+route
42 equally ranked IID candidates
SHELLACSHELLAC46N107B71OTABLET, EXTENDED RELEASE / ORAL213.24 mgExact identifier — unii+route
24 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CONCENTRATE / ORAL7000 mgExact identifier — unii+route
40 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, CHEWABLE / ORAL48 mgExact identifier — unii+route
42 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE / ORAL1072 mgExact identifier — unii+route
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SYRUP / ORAL5700 mgExact identifier — unii+route
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION, EXTENDED RELEASE / ORAL1000 mgExact identifier — unii+route
40 equally ranked IID candidates
SHELLACSHELLAC46N107B71OTABLET, SUGAR COATED / ORALNAExact identifier — unii+route
24 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE / ORAL1072 mgExact identifier — unii+route
40 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, FILM COATED, EXTENDED RELEASE / ORAL17 mgExact identifier — unii+route
42 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET / ORAL64 mgExact identifier — unii+route
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii+route
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3ELIXIR / ORAL9306 mgExact identifier — unii+route
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii+route
40 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ECAPSULE, DELAYED RELEASE / ORALNAExact identifier — unii+route
42 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, EXTENDED RELEASE / ORAL9 mgExact identifier — unii+route
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, COATED / ORAL16 mgExact identifier — unii+route
40 equally ranked IID candidates
SHELLACSHELLAC46N107B71OSUSPENSION / ORAL3 mg/1mlExact identifier — unii+route
24 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ESOLUTION / ORAL3000 mgExact identifier — unii+route
42 equally ranked IID candidates
SHELLACSHELLAC46N107B71OCAPSULE, EXTENDED RELEASE / ORAL75.01 mgExact identifier — unii+route
24 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, LIQUID FILLED / ORAL12 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SHELLACSHELLAC46N107B71OCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii+route
24 equally ranked IID candidates
SHELLACSHELLAC46N107B71OCAPSULE, EXTENDED RELEASE / ORAL75.01 mgExact identifier — unii+route
24 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ECAPSULE, DELAYED RELEASE PELLETS / ORAL32 mgExact identifier — unii+route
42 equally ranked IID candidates
SHELLACSHELLAC46N107B71OCAPSULE, DELAYED RELEASE / ORAL1 mgExact identifier — unii+route
24 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, FOR SUSPENSION / ORAL2 mgExact identifier — unii+route
42 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, LIQUID FILLED / ORAL1 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route
42 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, DELAYED RELEASE / ORAL1.7 mgExact identifier — unii+route
40 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ECAPSULE, DELAYED RELEASE PELLETS / ORAL32 mgExact identifier — unii+route
42 equally ranked IID candidates
SHELLACSHELLAC46N107B71OSUSPENSION / ORAL3 mg/1mlExact identifier — unii+route
24 equally ranked IID candidates
SHELLACSHELLAC46N107B71OCAPSULE, DELAYED RELEASE / ORAL1 mgExact identifier — unii+route
24 equally ranked IID candidates
SHELLACSHELLAC46N107B71OCAPSULE, COATED PELLETS / ORAL29 mgExact identifier — unii+route
24 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, LIQUID FILLED / ORAL12 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, FOR SUSPENSION / ORAL2 mgExact identifier — unii+route
42 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ECAPSULE / ORAL300 mgExact identifier — unii+route
42 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ECAPSULE, EXTENDED RELEASE / ORAL56 mgExact identifier — unii+route
42 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
Alka-Seltzer Plus Severe Sinus Cold and Cough Liquid GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.0dba1329-5b0d-5688-e054-00144ff8d46c2025-12-04WarningsExact identifier
ndc (package): 0280-0507-20
ndc (product): 0280-0507
ndc11 (package): 00280050720
spl id: 452662db-192f-a610-e063-6394a90a4a10
spl set id: 0dba1329-5b0d-5688-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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