Alka-Seltzer Plus Day Severe Cold Plus Flu

Manufacturer
Bayer HealthCare LLC. | Contract Pharmacal Corp.
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 01:32:11

Label at a glance#

ProductAlka-Seltzer Plus Day Severe Cold Plus Flu
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relieves these symptoms due to a cold or flu: minor aches and pains headache sore throat cough nasal congestion sinus congestion and pressure helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus temporarily reduces fever

Dosage and administration

do not take more than the recommended dose take every 4 hours; do not exceed 6 packets in 24 hours or as directed by a doctor adults and children 12 years and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. children under 12 years: do not use

Storage and handling

each packet contains: potassium 5 mg and sodium 6 mg store at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each packet)Purposes
Acetaminophen 500 mgPain reliever/fever reducer
Dextromethorphan hydrobromide 20 mgCough suppressant
Guaifenesin 400 mgExpectorant
Phenylephrine hydrochloride 10 mgNasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms due to a cold or flu:
    • minor aches and pains
    • headache
    • sore throat
    • cough
    • nasal congestion
    • sinus congestion and pressure
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
  • temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

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

  • more than 6 packets 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

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.

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 - ASK DOCTOR 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 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
  • take every 4 hours; do not exceed 6 packets in 24 hours or as directed by a doctor
  • adults and children 12 years and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
  • children under 12 years: do not use

Other information

STORAGE AND HANDLING SECTION

  • each packet contains: potassium 5 mg and sodium 6 mg
  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, anhydrous citric acid, compressible sugar, D&C yellow #10, dental-type silica, FD&C red #40, flavors, maltodextrin, povidone, pregelatinized starch, silicon dioxide, sodium citrate, stearic acid, sucralose, tartaric acid, tribasic calcium phosphate

Questions or comments?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Dist. by: Bayer HealthCare LLC
Whippany, NJ 07981

PRINCIPAL DISPLAY PANEL - 6 Packet Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alka-Seltzer PLUS ®

Severe Cold & Flu

Honey Lemon Zest

Fast Relief Mix-In Packets

Day NON-DROWSY

Acetaminophen / Pain reliever-fever reducer

Phenylephrine HCl / Nasal decongestant

Dextromethorphan HBr / Cough suppressant

Guaifenesin / Expectorant

• Nasal Congestion

• Headache
• Sore Throat

• Body Ache

• Cough
• Mucus

• Chest Congestion

• Fever

6 PACKETS

Carton 6Carton 6

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1550968acetaminophen 500 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG Powder for Oral SolutionPSN11
1550968acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG Powder for Oral SolutionSCD11
1550968acetaminophen 500 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG Granules for Oral SolutionSY11
1550968APAP 500 MG / Dextromethorphan Hydrobromide 20 MG / Guaifenesin 400 MG / Phenylephrine Hydrochloride 10 MG Powder for Oral SolutionSY11

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130016500559429GTIN-13: 0016500559429
EAN-13: 0016500559429
GTIN-12: 016500559429
UPC-A: 016500559429
GTIN storage (14 digits): 00016500559429
431296_C7506_ASP_Severe_Cold_Flu_Day_Powder_Ctn_FDA1reduced.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-0921-06Alka-Seltzer Plus Day Severe Cold Plus Flu1 in 1 PACKETPOWDER, FOR SOLUTION111
0280-0921-06Alka-Seltzer Plus Day Severe Cold Plus Flu6 in 1 CARTONPOWDER, FOR SOLUTION611

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0280-0921-06EA - Each0280-0921ebaf37ed-0c60-442b-bf4a-ddc1ebda33f112019-09-05

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
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G91
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3G1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2D1
POVIDONESINACTIVE INGREDIENTFZ989GH94E1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD41
TARTARIC ACIDINACTIVE INGREDIENTW4888I119H1
TRIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENT91D9GV0Z281

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0280-09210280-0921-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 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 3 · 126 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POVIDONESPOVIDONEFZ989GH94ECAPSULE, DELAYED RELEASE PELLETS / ORAL32 mgExact identifier — unii+route
42 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, ORALLY DISINTEGRATING / ORAL10 mgExact identifier — unii+route
24 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DFILM, SOLUBLE / ORAL19 mgExact identifier — unii+route
30 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATETRIBASIC CALCIUM PHOSPHATE91D9GV0Z28CAPSULE / ORAL176 mgExact identifier — unii+route
16 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APEMULSION / ORALNAExact identifier — unii+route
24 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94EPOWDER, FOR SUSPENSION / ORAL35 mg/5mlExact identifier — unii+route
42 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, FILM COATED, EXTENDED RELEASE / ORALNAExact identifier — unii+route
30 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATETRIBASIC CALCIUM PHOSPHATE91D9GV0Z28TABLET / ORAL330 mgExact identifier — unii+route
16 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DSOLUTION / ORAL1451 mgExact identifier — unii+route
30 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94EPOWDER, FOR SUSPENSION / ORAL35 mg/5mlExact identifier — unii+route
42 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETROCHE / ORAL30 mgExact identifier — unii+route
42 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATETRIBASIC CALCIUM PHOSPHATE91D9GV0Z28TABLET, DELAYED RELEASE / ORAL333.3 mgExact identifier — unii+route
16 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCAPSULE, EXTENDED RELEASE / ORAL64 mgExact identifier — unii+route
24 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETROCHE / ORAL30 mgExact identifier — unii+route
42 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DPASTE / ORAL1050 mgExact identifier — unii+route
30 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCAPSULE, EXTENDED RELEASE / ORAL64 mgExact identifier — unii+route
24 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ECAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii+route
42 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, CHEWABLE / ORAL180 mgExact identifier — unii+route
24 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route
24 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94EGRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL350 mgExact identifier — unii+route
42 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER, FOR SOLUTION / ORAL280 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TARTARIC ACIDTARTARIC ACIDW4888I119HPOWDER, FOR SOLUTION / ORAL270 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DGRANULE, FOR SUSPENSION / ORAL952 mgExact identifier — unii+route
30 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATETRIBASIC CALCIUM PHOSPHATE91D9GV0Z28TABLET / ORAL330 mgExact identifier — unii+route
16 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route
24 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ECAPSULE, DELAYED RELEASE / ORALNAExact identifier — unii+route
42 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APPOWDER, FOR SUSPENSION / ORAL1203 mg/5mlExact identifier — unii+route
24 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ESUSPENSION / ORAL20 mg/5mlExact identifier — unii+route
42 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLPOWDER, FOR SOLUTION / ORAL123 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATETRIBASIC CALCIUM PHOSPHATE91D9GV0Z28TABLET, CHEWABLE / ORAL130 mgExact identifier — unii+route
16 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED, EXTENDED RELEASE / ORAL120 mgExact identifier — unii+route
24 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, ORALLY DISINTEGRATING / ORAL12 mgExact identifier — unii+route
30 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, FILM COATED, EXTENDED RELEASE / ORAL17 mgExact identifier — unii+route
42 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, CHEWABLE / ORAL48 mgExact identifier — unii+route
42 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATETRIBASIC CALCIUM PHOSPHATE91D9GV0Z28TABLET, EXTENDED RELEASE / ORAL750 mgExact identifier — unii+route
16 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, EXTENDED RELEASE / ORAL101 mgExact identifier — unii+route
42 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DPOWDER, FOR SUSPENSION / ORAL8000 mgExact identifier — unii+route
30 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ECAPSULE, COATED PELLETS / ORAL10.03 mgExact identifier — unii+route
42 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, DELAYED RELEASE / ORAL53 mgExact identifier — unii+route
42 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, COATED / ORAL49.2 mgExact identifier — unii+route
42 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9POWDER, FOR SOLUTION / ORAL117 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route
42 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATETRIBASIC CALCIUM PHOSPHATE91D9GV0Z28TABLET, FILM COATED / ORAL21.8 mgExact identifier — unii+route
16 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATETRIBASIC CALCIUM PHOSPHATE91D9GV0Z28CAPSULE, EXTENDED RELEASE / ORAL32.73 mgExact identifier — unii+route
16 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, FOR SUSPENSION / ORAL2 mgExact identifier — unii+route
42 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET / ORAL320 mgExact identifier — unii+route
30 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DPASTE / ORAL1050 mgExact identifier — unii+route
30 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED, EXTENDED RELEASE / ORAL120 mgExact identifier — unii+route
24 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, COATED / ORAL5.6 mgExact identifier — unii+route
30 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ECAPSULE, COATED PELLETS / ORAL10.03 mgExact identifier — unii+route
42 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DCAPSULE / ORAL200 mgExact identifier — unii+route
30 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, ORALLY DISINTEGRATING / ORAL10 mgExact identifier — unii+route
24 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAPOWDER, FOR SOLUTION / ORAL0.33 mg/5mlExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94EDROPS / ORALNAExact identifier — unii+route
42 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, COATED / ORAL42.4 mgExact identifier — unii+route
24 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, DELAYED RELEASE / ORAL53 mgExact identifier — unii+route
42 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94EGRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL350 mgExact identifier — unii+route
42 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DFILM, SOLUBLE / ORAL19 mgExact identifier — unii+route
30 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, FILM COATED, EXTENDED RELEASE / ORAL17 mgExact identifier — unii+route
42 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLPOWDER, FOR SOLUTION / ORAL123 mgExact identifier — unii+route+dosage form
2 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 Day Severe Cold Plus FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.cec51eab-cce3-4965-a14e-a46d953050c42026-01-08WarningsExact identifier
ndc (package): 0280-0921-06
ndc (product): 0280-0921
ndc11 (package): 00280092106
spl id: 47e32f69-3232-a960-e063-6394a90a8590
spl set id: cec51eab-cce3-4965-a14e-a46d953050c4

Reported adverse events (FAERS/openFDA)#

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