Label: ALKA-SELTZER PLUS COLD AND FLU- chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide tablet tablet, effervescent tablet, effervescent

  • NDC Code(s): 29485-7318-2, 29485-7318-3
  • Packager: Lil' Drug Store Products, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 6, 2023

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredients (in each tablet)

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

  • Purpose

    Pain reliever/fever reducer
    Antihistamine
    Cough suppressant
    Nasal decongestant

  • 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

    • 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!

  • 25 Count Box

    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 box

  • 30 Count Box

    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 box

  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER PLUS COLD AND FLU 
    chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide tablet tablet, effervescent tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-7318
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    MANNITOL (UNII: 3OWL53L36A)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize25mm
    FlavorCITRUSImprint Code ASP;FLU
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29485-7318-225 in 1 BOX12/23/202112/31/2025
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:29485-7318-330 in 1 BOX12/23/202112/31/2025
    22 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01312/23/202112/31/2025
    Labeler - Lil' Drug Store Products, Inc. (093103646)