Alka-Seltzer Plus Cold and Flu

Manufacturer
Lil' Drug Store Products, Inc.
Effective date
2024-11-25
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:39:30

Label at a glance#

ProductAlka-Seltzer Plus Cold and Flu, CVP
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE
Label structure14 sections

Indications and uses

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

Dosage and administration

Directions do not take more than the recommended dose 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

Storage and handling

Other information each tablet contains : potassium 80 mg; sodium 356 mg store at room temperature. Avoid excessive heat.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each tablet)
Acetaminophen 250 mg
Chlorpheniramine maleate 2 mg
Dextromethorphan hydrobromide 10 mg
Phenylephrine hydrochloride 5 mg

Purposes

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 or flu:
  • minor aches and pains
  • headache
  • cough
  • sore throat
  • runny nose
  • sneezing
  • nasal and sinus congestion
  • temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert

SPL UNCLASSIFIED SECTION

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

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.

SPL UNCLASSIFIED SECTION

Do not use to sedate children

Do not use

OTC - DO NOT USE SECTION

Do not use

  • 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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • 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
  • a sodium restricted diet

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

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

OTC - WHEN USING SECTION

When using this product

  • 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

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • 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

Directions

  • do not take more than the recommended dose
  • 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

STORAGE AND HANDLING SECTION

Other information

  • each tablet contains: potassium 80 mg; sodium 356 mg
  • store at room temperature. Avoid excessive heat.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients
anhydrous citric acid, calcium silicate, dimethicone, FD&C red #40, FD&C yellow #6, flavors, magnesium stearate, maltodextrin,
mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

DO NOT USE IF INNER POUCH OR CARTON IS OPEN OR DAMAGED!
PACKAGE NOT CHILD RESISTANT!

PDP/Package - Lil Drug Store

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alka-

Seltzer

Plus ®

CITRUS

FLAVOR

SEVERE Cold & Flu

POWERFAST FIZZ™

ACETAMINOPHEN/Pain Reliever-Fever Reducer

Chlorpheniramine Maleate/Antihistamine

Dextromethorphan HBr/Cough Suppressant

Phenylephrine Hydrochloride/Nasal Decongestant

  • Fever & ​Body Ache
  • Cough
  • Nasal Congestion
  • Runny Nose
  • Sore Throat

4

Effervescent Tablets

[Lil' Drug Store logo]

PDP/PackagePDP/Package

PDP/Package - BASIX

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alka-

Seltzer

Plus ®

CITRUS

FLAVOR

SEVERE Cold & Flu

POWERFAST FIZZ™

ACETAMINOPHEN/Pain Reliever-Fever Reducer

Chlorpheniramine Maleate/Antihistamine

Dextromethorphan HBr/Cough Suppressant

Phenylephrine Hydrochloride/Nasal Decongestant

  • Fever & ​Body Ache
  • Cough
  • Nasal Congestion
  • Runny Nose
  • Sore Throat

4

Effervescent Tablets

[TRAVEL

BASIX logo]

PDP/PackagePDP/Package

PDP/Package - Alka-Selter Plus Cold & Flu, CVP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alka-

Seltzer

Plus ®

CITRUS

FLAVOR

SEVERE Cold & Flu

POWERFAST FIZZ™

ACETAMINOPHEN/Pain Reliever-Fever Reducer

Chlorpheniramine Maleate/Antihistamine

Dextromethorphan HBr/Cough Suppressant

Phenylephrine Hydrochloride/Nasal Decongestant

  • Fever & ​Body Ache
  • Cough
  • Nasal Congestion
  • Runny Nose
  • Sore Throat

​

4

Effervescent Tablets

[CVP HEALTH logo]

PDP/PackagePDP/Package

Alka-Seltzer Plus Cold & Flu, 25ct Unit Dose Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alka-

Seltzer

PLUS ®

CITRUS

FLAVOR

SEVERE COLD & FLU

POWERFAST FIZZ™

ACETAMINOPHEN/Pain Reliever-Fever Reducer

Chlorpheniramine Maleate/Antihistamine

Dextromethorphan HBr/Cough Suppressant

Phenylephrine Hydrochloride/Nasal Decongestant

  • Fever & ​Body Ache
  • Cough
  • Nasal Congestion
  • Runny Nose
  • Sore Throat

2 EFFERVESCENT TABLETS PER POUCH

​PDP/PackagePDP/Package

Alka-Seltzer Plus Cold & Flu, 30ct Unit Dose Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alka-

Seltzer

PLUS ®

CITRUS

FLAVOR

SEVERE COLD & FLU

POWERFAST FIZZ™

ACETAMINOPHEN/Pain Reliever-Fever Reducer

Chlorpheniramine Maleate/Antihistamine

Dextromethorphan HBr/Cough Suppressant

Phenylephrine Hydrochloride/Nasal Decongestant

  • Fever & ​Body Ache
  • Cough
  • Nasal Congestion
  • Runny Nose
  • Sore Throat

2 EFFERVESCENT TABLETS PER POUCH

PDP/PackagePDP/Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1536477acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Effervescent Oral TabletPSN4
1536477acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Effervescent Oral TabletSCD4
1536477APAP 250 MG / Chlorpheniramine Maleate 2 MG / Dextromethorphan Hydrobromide 10 MG / Phenylephrine Hydrochloride 5 MG Effervescent Oral TabletSY4

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66715-6531-2Alka-Seltzer Plus Cold and Flu, CVP2 in 1 POUCHTABLET, EFFERVESCENT24
66715-6531-2Alka-Seltzer Plus Cold and Flu, CVP2 in 1 CARTONTABLET, EFFERVESCENT24
66715-7831-2Alka-Seltzer Plus Cold and Flu, BASIX2 in 1 CARTONTABLET, EFFERVESCENT24
66715-7831-2Alka-Seltzer Plus Cold and Flu, BASIX2 in 1 POUCHTABLET, EFFERVESCENT24
66715-9831-2Alka-Seltzer Plus Cold and Flu2 in 1 CARTONTABLET, EFFERVESCENT24
66715-9831-2Alka-Seltzer Plus Cold and Flu2 in 1 POUCHTABLET, EFFERVESCENT24
66715-9831-8Alka-Seltzer Plus Cold and Flu25 in 1 BOX, UNIT-DOSETABLET, EFFERVESCENT254
66715-9831-9Alka-Seltzer Plus Cold and Flu30 in 1 BOX, UNIT-DOSETABLET, EFFERVESCENT304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-6531ALKA-SELTZER PLUS COLD AND FLU, CVP (CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE TABLET) TABLET, EFFERVESCENT ALKA-SELTZER PLUS COLD AND FLU, BASIX (CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE TABLET) TABLET, EFFERVESCENT ALKA-SELTZER PLUS COLD AND FLU (CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE TABLET) TABLET, EFFERVESCENT [LIL' DRUG STORE PRODUCTS, INC.]4Current NDC, 2 package rows20241127_e7a27773-69d6-9e07-e053-2a95a90af8ea.zip
66715-7831ALKA-SELTZER PLUS COLD AND FLU, CVP (CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE TABLET) TABLET, EFFERVESCENT ALKA-SELTZER PLUS COLD AND FLU, BASIX (CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE TABLET) TABLET, EFFERVESCENT ALKA-SELTZER PLUS COLD AND FLU (CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE TABLET) TABLET, EFFERVESCENT [LIL' DRUG STORE PRODUCTS, INC.]4Current NDC, 2 package rows20241127_e7a27773-69d6-9e07-e053-2a95a90af8ea.zip
66715-9831ALKA-SELTZER PLUS COLD AND FLU, CVP (CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE TABLET) TABLET, EFFERVESCENT ALKA-SELTZER PLUS COLD AND FLU, BASIX (CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE TABLET) TABLET, EFFERVESCENT ALKA-SELTZER PLUS COLD AND FLU (CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE TABLET) TABLET, EFFERVESCENT [LIL' DRUG STORE PRODUCTS, INC.]4Current NDC, Legacy NDC, 4 package rows20241127_e7a27773-69d6-9e07-e053-2a95a90af8ea.zip

Products#

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

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

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 48 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 Flu, CVPCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE TABLETLil' Drug Store Products, Inc.e7a27773-69d6-9e07-e053-2a95a90af8ea2024-11-25WarningsExact identifier
ndc (package): 66715-7831-2
ndc (package): 66715-9831-9
ndc (package): 66715-9831-2
ndc (package): 66715-9831-8
ndc (package): 66715-6531-2
ndc (product): 66715-7831
ndc (product): 66715-9831
ndc (product): 66715-6531
ndc11 (package): 66715653102
ndc11 (package): 66715983102
ndc11 (package): 66715983108
ndc11 (package): 66715783102
ndc11 (package): 66715983109
spl id: 27c33a7d-6d48-b04c-e063-6294a90a77e2
spl set id: e7a27773-69d6-9e07-e053-2a95a90af8ea

Reported adverse events (FAERS/openFDA)#

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