Alka-Seltzer Plus® Cold & Cough Effervescent Tablets

Manufacturer
Bayer HealthCare LLC.
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:19:54

Label at a glance#

ProductAlka-Seltzer Plus Cold and Cough
Active ingredientASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE
Label structure16 sections

Indications and uses

Uses  temporarily relieves these symptoms due to a cold with cough:  ·minor aches and pains  ·headache  ·cough  ·runny nose  ·nasal and sinus congestion  ·sneezing  ·sore throat  ·temporarily reduces fever

Dosage and administration

Directions ● 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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each tablet)

Aspirin 325 mg (NSAID)*

Chlorpheniramine maleate 2 mg

Dextromethorphan hydrobromide 10 mg

Phenylephrine bitartrate 7.8 mg

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Purposes

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

Uses

 temporarily relieves these symptoms due to a cold with cough:

 ·minor aches and pains  ·headache  ·cough

 ·runny nose  ·nasal and sinus congestion

 ·sneezing  ·sore throat

 ·temporarily reduces fever

WARNINGS SECTION

Warnings

Reye’s syndrome: 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: Aspirin may cause a severe allergic reaction which may

include:

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

Stomach bleeding warning: 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: 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.

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if

● 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

● 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

● a sodium-restricted diet

OTC - WHEN USING SECTION

When using this product

● do not exceed recommended dosage

 may cause marked drowsiness

● avoid alcoholic drinks

● excitability may occur, especially in children

● 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

Stop use and ask a doctor if

● 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, 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

 ringing in the ears or a loss of hearing occurs

 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.

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

Directions

● 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

OTHER SAFETY INFORMATION

Other information

● each tablet contains: sodium 416 mg

● Phenylketonurics: Contains Phenylalanine 9 mg Per Tablet

● store at room temperature. Avoid excessive heat.

INACTIVE INGREDIENT SECTION

Inactive ingredients acesulfame potassium, anhydrous citric

acid, aspartame, calcium silicate, dimethicone, docusate sodium, FD&C

red #40, flavors, mannitol, povidone, sodium benzoate, sodium

bicarbonate

Questions or comments?

OTC - QUESTIONS SECTION

Questions or comments?1-800-986-0369 (Mon - Fri 9AM -

5PM EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alka-Seltzer

PLUS®

Cold &

Cough

CITRUS

ASPIRIN (NSAID) / Pain Reliever/Fever Reducer

Chlorpheniramine Maleate/Antihistamine

Dextromethorphan HBr/Cough Suppresant

Phenylephrine Bitartrate/Nasal Decongestant

  • Cough
  • Nasal Congestion
  • Runny Nose
  • Headache & Body Ache
  • Sinus Pressure

20 EFFERVESCENT TABLETS

Package labelPackage label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1537029aspirin 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral TabletPSN6
1537029aspirin 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral TabletSCD6
1537029ASA 325 MG / Chlorpheniramine Maleate 2 MG / Dextromethorphan Hydrobromide 10 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral TabletSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-1555-20Alka-Seltzer Plus Cold and Cough2 in 1 POUCHTABLET, EFFERVESCENT26
0280-1555-20Alka-Seltzer Plus Cold and Cough10 in 1 CARTONTABLET, EFFERVESCENT106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0280-1555-20EA - Each0280-15551bc155ed-71b9-436f-8546-43bfdcef827412022-06-06

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0280-15550280-1555-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alka-Seltzer Plus Cold and CoughASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.75862805-2cfe-fb45-e053-2991aa0a14032025-12-04WarningsExact identifier
ndc (package): 0280-1555-20
ndc (product): 0280-1555
ndc11 (package): 00280155520
spl id: 45267943-6d4f-45dd-e063-6294a90ab025
spl set id: 75862805-2cfe-fb45-e053-2991aa0a1403

Reported adverse events (FAERS/openFDA)#

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