ALKA SELTZER PLUS COLD (ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE) TABLET [NAVAJO MANUFACTURING COMPANY INC.]

ALKA SELTZER PLUS COLD (ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE) TABLET [NAVAJO MANUFACTURING COMPANY INC.]
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NDC 67751-142-01, 67751-142-02
Set ID 327ff300-ccb2-47ad-858d-e11b15049bb6
Category HUMAN OTC DRUG LABEL
Packager Navajo Manufacturing Company Inc.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART343
  • Drug Facts

  • Active ingredients (in each tablet)

    Aspirin 325 mg (NSAID)*

    Chlorpheniramine maleate 2 mg

    Phenylephrine bitartrate 7.8 mg

    *nonsteroidal anti-inflammatory drug

    Purposes

    Pain reliever/fever reducer

    Antihistamine

    Nasal decongestant

  • 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

    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

    • 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.
    • in children under 12 years of age

    • if you have had a allergic reaction to this product or any of its ingredients

    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 a doctor or pharmacist before use if you are

    • taking a prescription drug for •gout • diabetes • arthritis • taking sedatives or tranquilizers

    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 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 occurs

    If pregnant 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.

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

  • 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 information

    • do not use if pouch is opened • each tablet contains: sodium 474 mg
    • Phenylketonurics: Contains Phenylalanine 8.4 mg Per Tablet
    • store at room temperature. Avoid excessive heat.

  • Inactive ingredients 

    acesulfame potassium, anhydrous citric acid, aspartame, calcium silicate, dimethylpolysiloxane, docusate sodium, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

  • Questions or comments?

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

  • Package Labeling:

    Alka Seltzer Plus

  • INGREDIENTS AND APPEARANCE
    ALKA SELTZER PLUS COLD 
    aspirin, chlorpheniramine maleate, phenylephrine bitartrate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-142(NDC:0280-1400)
    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
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ASPARTAME (UNII: Z0H242BBR1)  
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    MANNITOL (UNII: 3OWL53L36A)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize25mm
    FlavorImprint Code ALKA;SELTZER;PLUS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67751-142-011 in 1 CARTON09/17/2016
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:67751-142-021 in 1 CARTON09/17/2016
    24 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34309/17/2016
    Labeler - Navajo Manufacturing Company Inc. (091917799)

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