ALKA SELTZER COLD Cold Flu Congestion Severe Fast Hot Liquid Day Night

Manufacturer
Bayer HealthCare LLC.
Effective date
2026-06-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-06-12 05:10:18

Label at a glance#

ProductALKA SELTZER COLD Cold Flu Congestion Severe Fast Hot Liquid Day Night
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE
Label structure18 sections

Indications and uses

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

Dosage and administration

do not take more than the recommended dose adults and children 12 years and over:take every 4 hours; do not exceed 6 packets in 24 hours or as directed by a doctor 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; sodium 5 mg store between 20 o C to 25 o C (68 o F to 77 o F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Alka-Seltzer COLD

Cold & Flu + Congestion Severe Day Powder Packets

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
    • sinus congestion and pressure
    • nasal congestion
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes cough more productive
  • 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

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

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

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
  • adults and children 12 years and over:take every 4 hours; do not exceed 6 packets in 24 hours or as directed by a doctor
  • 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; sodium 5 mg
  • store between 20 oC to 25 oC (68 oF to 77 oF)

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 8AM - 8PM EST)

SPL UNCLASSIFIED SECTION

Alka-Seltzer COLD
Cold & Flu + Congestion Severe Night Powder Packets

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

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 sek medical help right away.

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 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

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
  • 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

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
  • adults and children 12 years and over : take every 4 hours; do not exceed 5 packets in 24 hours or as directed by a doctor
  • 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; sodium 5 mg
  • store between 20 oC to 25 oC (68 oF to 77 oF)

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 8AM - 8PM EST)

SPL UNCLASSIFIED SECTION

Dist. by: Bayer HealthCare LLC
Whippany, NJ 07981

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130016500559405GTIN-13: 0016500559405
EAN-13: 0016500559405
GTIN-12: 016500559405
UPC-A: 016500559405
GTIN storage (14 digits): 00016500559405
Final Artwork ASC Cold Flu Cong Severe DN Powders 12ct.jpg

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0280-82840280-8284-12
0280-8273
0280-8272

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALKA SELTZER COLD Cold Flu Congestion Severe Fast Hot Liquid Day NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATEBayer HealthCare LLC.53715ea4-42b3-5887-e063-6294a90a42492026-06-04WarningsExact identifier
ndc (package): 0280-8284-12
ndc (product): 0280-8284
ndc11 (package): 00280828412
spl id: 53715ea4-42b4-5887-e063-6294a90a4249
spl set id: 53715ea4-42b3-5887-e063-6294a90a4249
ALKA SELTZER COLD Cold and Flu plus Congestion Severe Fast Hot Liquid NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.5349dbde-730c-610f-e063-6394a90a952a2026-06-02WarningsExact identifier
ndc (product): 0280-8272
ALKA SELTZER COLD Cold Flu And Congestion Severe Fast Hot Liquid DayACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.53371691-2510-5039-e063-6394a90a6ea92026-06-01WarningsExact identifier
ndc (product): 0280-8273

Reported adverse events (FAERS/openFDA)#

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