FDA.reportPublic FDA data

Alka-Seltzer Plus Night Severe Cold and Flu

Manufacturer
Bayer HealthCare LLC. | Contract Pharmacal Corp.
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:32:14

Label at a glance#

ProductAlka-Seltzer Plus Night Severe Cold and Flu
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relieves these symptoms due to a cold or flu: headache minor aches and pains cough sore throat nasal congestion sinus congestion and pressure runny nose sneezing temporarily reduces fever

Dosage and administration

do not take more than the recommended dose take every 4 hours; do not exceed 5 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 5 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 650 mgPain reliever/fever reducer
Dextromethorphan hydrobromide 20 mgCough suppressant
Doxylamine succinate 12.5 mgAntihistamine
Phenylephrine hydrochloride 10 mgNasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms due to a cold or flu:
    • headache
    • minor aches and pains
    • cough
    • sore throat
    • nasal congestion
    • sinus congestion and pressure
    • runny nose
    • sneezing
  • 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 5 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 to sedate children.

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
  • 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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • 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

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 5 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 5 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, pregelatinized starch, sodium citrate, 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

Night

Acetaminophen / Pain reliever-fever reducer

Doxylamine succinate / Antihistamine

Phenylephrine HCl / Nasal decongestant

Dextromethorphan HBr / Cough suppressant

• Nasal Congestion

• Headache

• Sore Throat

• Body Ache
• Cough

• Runny Nose

• Fever

6 PACKETS

Carton 6 packetsCarton 6 packets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1534835acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG Powder for Oral SolutionPSN10
1534835acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / doxylamine succinate 12.5 MG / phenylephrine hydrochloride 10 MG Powder for Oral SolutionSCD10
1534835acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / doxylamine succinate 12.5 MG / phenylephrine hydrochloride 10 MG Granules for Oral SolutionSY10
1534835APAP 650 MG / Dextromethorphan Hydrobromide 20 MG / doxylamine succinate 12.5 MG / Phenylephrine Hydrochloride 10 MG Powder for Oral SolutionSY10

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DOXYLAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-0922-06Alka-Seltzer Plus Night Severe Cold and Flu1 in 1 PACKETPOWDER, FOR SOLUTION110
0280-0922-06Alka-Seltzer Plus Night Severe Cold and Flu6 in 1 CARTONPOWDER, FOR SOLUTION610

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0280-0922-06EA - Each0280-0922a204e8b1-5393-48ba-82ac-8df2d8b4fc4112019-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D2
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYH2
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI22
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJ2
ACETAMINOPHENACTIVE MOIETY362O9ITL9D2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTS2
DOXYLAMINEACTIVE MOIETY95QB77JKPL2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MV2
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G92
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3G2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD42
TARTARIC ACIDINACTIVE INGREDIENTW4888I119H2
TRIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENT91D9GV0Z282

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0280-09220280-0922-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACESULFAME POTASSIUM23OV73Q5G9IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C RED NO. 40WZB9127XOAIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
SUCRALOSE96K6UQ3ZD4IACT
TARTARIC ACIDW4888I119HIACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
STARCH, CORNO8232NY3SJIACT
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
SUCROSEC151H8M554IACT
MENTHOLL7T10EIP3AIACT
LEMON24RS0A988OIACT
HONEYY9H1V576FHIACT
SILICON DIOXIDEETJ7Z6XBU4IACT

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 1 · 28 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
TRIBASIC CALCIUM PHOSPHATETRIBASIC CALCIUM PHOSPHATE91D9GV0Z28TABLET, CHEWABLE / ORAL130 mgExact identifier — unii+route
16 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATETRIBASIC CALCIUM PHOSPHATE91D9GV0Z28TABLET / ORAL330 mgExact identifier — unii+route
16 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATETRIBASIC CALCIUM PHOSPHATE91D9GV0Z28TABLET, EXTENDED RELEASE / ORAL750 mgExact identifier — unii+route
16 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATETRIBASIC CALCIUM PHOSPHATE91D9GV0Z28CAPSULE / ORAL176 mgExact identifier — unii+route
16 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATETRIBASIC CALCIUM PHOSPHATE91D9GV0Z28CAPSULE / ORAL176 mgExact identifier — unii+route
16 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GPOWDER, FOR SOLUTION / ORALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLPOWDER, FOR SOLUTION / ORAL123 mgExact identifier — unii+route+dosage form
2 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
SUCRALOSESUCRALOSE96K6UQ3ZD4POWDER, FOR SOLUTION / ORAL414 mgExact identifier — unii+route+dosage form
2 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, DELAYED RELEASE / ORAL333.3 mgExact identifier — unii+route
16 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATETRIBASIC CALCIUM PHOSPHATE91D9GV0Z28TABLET, COATED / ORAL40 mgExact identifier — unii+route
16 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
TRIBASIC CALCIUM PHOSPHATETRIBASIC CALCIUM PHOSPHATE91D9GV0Z28TABLET, COATED / ORAL40 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
TRIBASIC CALCIUM PHOSPHATETRIBASIC CALCIUM PHOSPHATE91D9GV0Z28TABLET / ORAL330 mgExact identifier — unii+route
16 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9POWDER, FOR SOLUTION / ORAL117 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9POWDER, FOR SOLUTION / ORAL117 mgExact identifier — unii+route+dosage form
2 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
TRIBASIC CALCIUM PHOSPHATETRIBASIC CALCIUM PHOSPHATE91D9GV0Z28TABLET, EXTENDED RELEASE / ORAL750 mgExact identifier — unii+route
16 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATETRIBASIC CALCIUM PHOSPHATE91D9GV0Z28TABLET, CHEWABLE / ORAL130 mgExact identifier — unii+route
16 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATETRIBASIC CALCIUM PHOSPHATE91D9GV0Z28TABLET, FILM COATED / ORAL21.8 mgExact identifier — unii+route
16 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GPOWDER, FOR SOLUTION / ORALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATETRIBASIC CALCIUM PHOSPHATE91D9GV0Z28TABLET, DELAYED RELEASE / ORAL333.3 mgExact identifier — unii+route
16 equally ranked IID candidates
TARTARIC ACIDTARTARIC ACIDW4888I119HPOWDER, FOR SOLUTION / ORAL270 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4POWDER, FOR SOLUTION / ORAL414 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

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 Night Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.f4c60ca1-ba59-4a92-84a5-6ba65faa56ab2026-01-08WarningsExact identifier
ndc (package): 0280-0922-06
ndc (product): 0280-0922
ndc11 (package): 00280092206
spl id: 47e3298a-8540-598c-e063-6294a90ada28
spl set id: f4c60ca1-ba59-4a92-84a5-6ba65faa56ab

Reported adverse events (FAERS/openFDA)#

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