ALKA-SELTZER PLUS COLD AND FLU

Manufacturer
Lil' Drug Store Products, Inc.
Effective date
2023-12-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:19:13

Label at a glance#

ProductALKA-SELTZER PLUS COLD AND FLU
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE
Label structure11 sections

Indications and 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 (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 250 mg
Chlorpheniramine maleate 2 mg
Dextromethorphan hydrobromide 10 mg
Phenylephrine hydrochloride 5 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Antihistamine
Cough suppressant
Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • 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.

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

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

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

  • 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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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!

25 Count Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alka-

Seltzer

Plus ®

SEVERE

Cold

& Flu

CITRUS

POWERFAST FIZZ™

ACETAMINOPHEN/Pain Reliever-Fever Reducer

Chlorpheniramine Maleate/Antihistamine

Dextromethorphan HBr/Cough Suppressant

Phenylephrine Hydrochloride/Nasal Decongestan

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

​[Bayer cross logo]

2 EFFERVESCENT TABLETS PER POUCH

Alka Seltzer Plus Cold and Flu 25 count boxAlka Seltzer Plus Cold and Flu 25 count box

30 Count Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alka-

Seltzer

Plus ®

SEVERE

Cold

& Flu

CITRUS

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

​[Bayer cross logo]

2 EFFERVESCENT TABLETS PER POUCH

Alka Seltzer Plus Cold and Flu 30 count boxAlka Seltzer Plus Cold and Flu 30 count box

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29485-7318ALKA-SELTZER PLUS COLD AND FLU (CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE TABLET TABLET, EFFERVESCENT) TABLET, EFFERVESCENT [LIL' DRUG STORE PRODUCTS, INC.]3Legacy NDC20231207_f0d36866-fd70-388b-e053-2995a90aca5f.zip

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
29485-731829485-7318-2, 29485-7318-3

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
0bde6cb8-4ea4-da1f-e063-6294a90a0fd4f0d36866-fd70-388b-e053-2995a90aca5f2023-12-06WarningsExact identifier
spl id: 0bde6cb8-4ea4-da1f-e063-6294a90a0fd4
spl set id: f0d36866-fd70-388b-e053-2995a90aca5f

Reported adverse events (FAERS/openFDA)#

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