Label: ALKA-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

  • NDC Code(s): 66715-6531-2, 66715-7831-2, 66715-9831-2, 66715-9831-8, view more
    66715-9831-9
  • Packager: Lil' Drug Store Products, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 12, 2023

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  • Drug Facts

  • Active ingredients

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

  • Purposes

    Purposes
    Pain reliever/fever reducer
    Antihistamine
    Cough suppressant
    Nasal decongestant

  • 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
  • Warnings

    Liver warning

    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

    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

    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

    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

    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

    • 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

    • 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, ask a health professional before use.

    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

    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

    Other information

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

    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?

    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

    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/Package

  • PDP/Package - BASIX

    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/Package

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

    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/Package

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

    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/Package

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

    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/Package

  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER PLUS COLD AND FLU, CVP 
    chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide tablet tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-6531
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MANNITOL (UNII: 3OWL53L36A)  
    Product Characteristics
    Colorwhite (speckled) Scoreno score
    ShapeROUNDSize25mm
    FlavorCITRUSImprint Code ASP;FLU
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-6531-22 in 1 CARTON08/01/2022
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/25/2022
    ALKA-SELTZER PLUS COLD AND FLU, BASIX 
    chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide tablet tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-7831
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MANNITOL (UNII: 3OWL53L36A)  
    Product Characteristics
    Colorwhite (speckled) Scoreno score
    ShapeROUNDSize25mm
    FlavorCITRUSImprint Code ASP;FLU
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-7831-22 in 1 CARTON11/30/2022
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/30/2022
    ALKA-SELTZER PLUS COLD AND FLU 
    chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide tablet tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-9831
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MANNITOL (UNII: 3OWL53L36A)  
    Product Characteristics
    Colorwhite (speckled) Scoreno score
    ShapeROUNDSize25mm
    FlavorCITRUSImprint Code ASP;FLU
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-9831-22 in 1 CARTON04/25/2022
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:66715-9831-825 in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product04/27/2022
    3NDC:66715-9831-930 in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product05/17/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/25/2022
    Labeler - Lil' Drug Store Products, Inc. (093103646)
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