Label: ALKA-SELTZER PLUS-D MULTI-SYMPTOM SINUS AND COLD- acetaminophen, dextromethorphan hydrobromide, chlorpheniramine maleate and pseudoephedrine hydrochloride capsule, liquid filled 

  • Label RSS
  • NDC Code(s): 0280-1197-20
  • Packager: Bayer HealthCare LLC, Consumer Care
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 05/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients (in each capsule) Purposes
    Acetaminophen 325 mg Pain reliever/fever reducer
    Chlorpheniramine maleate 2 mg Antihistamine
    Dextromethorphan hydrobromide 10 mg Cough suppressant
    Pseudoephedrine HCl 30 mg Nasal decongestant
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  • Uses

    • temporarily relieves these symptoms due to a cold:
      • minor aches and pains
      • headache
      • nasal congestion
      • sinus congestion and pressure
      • cough
      • sore throat
      • sneezing
      • runny nose
    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
      • runny nose
      • sneezing
      • itching of the nose or throat
      • itchy, watery eyes
    • temporarily reduces fever
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  • Warnings

    Liver warning

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

    • more than 8 capsules in 24 hours, which is the maximum daily amount for this product
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    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 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

    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.

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  • Directions

    • do not take more than the recommended dose
    • adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 8 capsules in 24 hours or as directed by a doctor.
    • children under 12 years: do not use
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  • Other information

    • each capsule contains: potassium 25 mg
    • store at room temperature. Avoid excessive heat.
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  • Inactive ingredients

    D&C red #33, FD&C blue #1, fractionated coconut, gelatin, glycerin, lecithin, polyethylene glycol, polyvinyl acetate phthalate, potassium acetate, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

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  • Questions or comments?

    1-800-986-0369 (Mon-Fri 9AM - 5PM EST) or www.alkaseltzerplus.com

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  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Bayer HealthCare LLC
    P.O. Box 1910
    Morristown, NJ 07962-1910

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  • PRINCIPAL DISPLAY PANEL - 20 Capsule Blister Pack Carton

    NEW!

    Alka-
    Seltzer
    PLUS®-D

    Acetaminophen / Pain reliever-fever
    reducer • Chlorpheniramine
    maleate / Antihistamine
    • Dextromethorphan hydrobromide / Cough
    suppressant • Pseudoephedrine HCl /
    Nasal decongestant

    MULTI-SYMPTOM

    SINUS & COLD
    FORMULA

    BAYER

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

    20 LIQUID GELS (Liquid Filled Capsules)

    PRINCIPAL DISPLAY PANEL - 20 Capsule Blister Pack Carton
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  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER PLUS-D MULTI-SYMPTOM SINUS AND COLD 
    acetaminophen, dextromethorphan hydrobromide, chlorpheniramine maleate, and pseudoephedrine hydrochloride capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0280-1197
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Acetaminophen (Acetaminophen) Acetaminophen 325 mg
    Dextromethorphan hydrobromide (Dextromethorphan) Dextromethorphan hydrobromide 10 mg
    chlorpheniramine maleate (chlorpheniramine) chlorpheniramine maleate 2 mg
    pseudoephedrine Hydrochloride (pseudoephedrine) pseudoephedrine Hydrochloride 30 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C red NO. 33  
    FD&C blue NO. 1  
    medium-chain triglycerides  
    gelatin  
    glycerin  
    Lecithin, Soybean  
    polyethylene glycol 400  
    polyvinyl acetate phthalate  
    potassium acetate  
    povidone K30  
    propylene glycol  
    water  
    sorbitan  
    sorbitol  
    titanium dioxide  
    Product Characteristics
    Color PURPLE Score no score
    Shape OVAL Size 20mm
    Flavor Imprint Code AS;D
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0280-1197-20 1 in 1 CARTON
    1 20 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 08/01/2013
    Labeler - Bayer HealthCare LLC, Consumer Care (785159372)
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