Label: ALKA-SELTZER PLUS COLD ORANGE ZEST- aspirin, chlorpheniramine maleate, phenylephrine bitartrate tablet, effervescent

  • 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 November 21, 2022

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

  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)

    Aspirin 325 mg (NSAID)*

    Chlorpheniramine maleate 2 mg

    Phenylephrine bitartrate 7.8 mg

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Purposes

    Pain reliever/fever reducer

    Antihistamine

    Nasal decongestant

  • INDICATIONS & USAGE

    Uses

    · temporarily relieves these symptoms due to a cold:

    · minor aches and pains · headache · runny nose

    · nasal and sinus congestion · sneezing · sore throat

    · temporarily reduces fever

  • WARNINGS

    Warnings

    Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

    Allergy alert: Aspirin may cause a severe allergic reaction which may include:

    ● hives ● facial swelling ● asthma (wheezing) ● shock

    Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

    ● are age 60 or older

    ● have had stomach ulcers or bleeding problems

    ● take a blood thinning (anticoagulant) or steroid drug

    ● take other drugs containing prescription or nonprescription NSAIDs

    (aspirin, ibuprofen, naproxen, or others)

    ● have 3 or more alcoholic drinks every day while using this product

    ● take more or for a longer time than directed

    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

    ● if you are allergic to aspirin or any other pain reliever/fever reducer

    ● 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 DOCTOR

    Ask a doctor before use if

    ● stomach bleeding warning applies to you

    ● you have a history of stomach problems, such as heartburn

    ● you have high blood pressure, heart disease, liver cirrhosis,

    or kidney disease

    ● you are taking a diuretic

    ● you have

    ● asthma ● diabetes

    ● thyroid disease ● glaucoma

    ● difficulty in urination due to enlargement of the prostate gland

    ● a breathing problem such as emphysema or chronic bronchitis

    ● a sodium-restricted diet

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    · taking a prescription drug for

    · gout · diabetes · arthritis

    · taking sedatives or tranquilizers

  • WHEN USING

    When using this product

    do not exceed recommended dosage

    ● excitability may occur, especially in children

    ● you may get drowsy

    ● avoid alcoholic drinks

    ● alcohol, sedatives, and tranquilizers may increase drowsiness

    ● be careful when driving a motor vehicle or operating machinery

  • STOP USE

    Stop use and ask a doctor if

    ● an allergic reaction occurs. Seek medical help right away.

    ● you experience any of the following signs of stomach bleeding

    ● feel faint ● vomit blood ● have bloody or black stools

    ● have stomach pain that does not get better

    ● pain 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

    ● ringing in the ears or a loss of hearing occurs

    ● nervousness, dizziness, or sleeplessness occur

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

    It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    ● 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 SAFETY INFORMATION

    Other information
    ● each tablet contains: sodium 476 mg
    ● Phenylketonurics: Contains Phenylalanine 9 mg Per Tablet

    ● store at room temperature. Avoid excessive heat.

  • INACTIVE INGREDIENT

    Inactive ingredients acesulfame potassium, anhydrous citric acid, aspartame, calcium silicate, dimethicone, docusate sodium, FD&C red #40, FD&C yellow #6, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    ALka-

    Seltzer®

    PLUS

    Cold

    ORANGE ZEST

    ASPIRIN (NSAID)/Pain Reliever-Fever Reducer

    Chlorpheniramine Maleate/Antihistamine

    Phenylephrine Bitartrate/Nasal Decongestant

    • Nasal Congestion
    • Runny Nose
    • Sore Throat
    • Headache & Body Ache
    • Sinus Pressure

    20 EFFERVESCENT TABLETS

    Carton 20 count

  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER PLUS COLD ORANGE ZEST 
    aspirin, chlorpheniramine maleate, phenylephrine bitartrate tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-1510
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
    PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE7.8 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    MANNITOL (UNII: 3OWL53L36A)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    Product Characteristics
    Colorwhite (White with orange and black flecks) Scoreno score
    ShapeROUNDSize25mm
    FlavorORANGEImprint Code Alka;Seltzer
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-1510-2010 in 1 CARTON07/15/2017
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/15/2017
    Labeler - Bayer HealthCare LLC. (112117283)