LEADER EFFERVESCENT ANTACID AND PAIN RELIEF (ASPIRIN, CITRIC ACID, SODIUM BICARBONATE) TABLET, EFFERVESCENT [CARDINAL HEALTH]

LEADER EFFERVESCENT ANTACID AND PAIN RELIEF (ASPIRIN, CITRIC ACID, SODIUM BICARBONATE) TABLET, EFFERVESCENT [CARDINAL HEALTH]
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NDC 70000-0421-1
Set ID 87c5276e-9531-0c5a-e053-2a95a90aa9e0
Category HUMAN OTC DRUG LABEL
Packager Cardinal Health
Generic Name
Product Class Anti-coagulant
Product Number
Application Number PART343
  • Purpose

    Anhydrous citric acid 1000mg...................Antacid

    Aspirin 325mg...........................................Pain reliever

    Sodium bicarbonate 1916mg....................Antacid

  • Active Ingredients

    (in each effervescent tablet)

    Anhydrous citric acid 1000mg

    Aspirin 325mg (NSAID)*

    Sodium bicarbonate 1916mg

    *Nonsteroidal anti-inflammatory drug

  • Uses

    for the temporary relief of ■ heartburn, acid indigestion and sour stomach when accompanied by headache or body aches and pains

    ■ upset stomach with headache from overindulgence in food or drink ■ pain alone (headaches or body aches and pains)

  • 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 a nonsteroidal anti-inflammatory drug (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

  • Do not use

    ■ if you have ever had an allergic reaction to any other pain reliever/fever reducer ■ if you are allergic to aspirin ■ if overly full from food or drink. Ask a doctor if severe stomach pain occurs after taking this product.

  • 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 a sodium-restricted diet

  • Ask a doctor or pharmacist before use if you are

    ■ presently taking a prescription drug. Antacids may interact with certain prescription drugs. ■ taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout or arthritis

  • When using this product

    do not take more than 8 tablets (adults) or 4 tablets (60 years and over) in a 24-hour period or use the maximum dosage for more than 10 days

  • Stop use and ask a doctor if

    ■ 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

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

    ■ pain lasts for more than 10 days or gets worse

    ■ new symptoms occur ■ redness or swelling is present

    ■ ringing in the ears or a loss of hearing occurs

  • 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. 1-800-222-1222

  • Directions

    ■ do not exceed recommended dosage

    ■ to avoid serious injury, completely dissolve tablets in 4 oz. of water before taking

    adults and children 12 years and over (up to 60 years of age): 2 tablets every 4 hours or as directed by a doctor

    do not exceed 8 tablets in 24 hours

    60 years and over: 2 tablets every 4 hours or as directed by a doctor

    do not exceed 4 tablets in 24 hours

    Children under 12 years: consult a doctor

  • Other information

    each tablet contains: sodium 524 mg

    ■ store at room temperature (59º-86ºF)

  • Inactive ingredients

    ■ none

  • Questions or comments?

    Call 1-888-228-6931

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Leader Pain 36ct

  • INGREDIENTS AND APPEARANCE
    LEADER EFFERVESCENT ANTACID AND PAIN RELIEF 
    aspirin, citric acid, sodium bicarbonate tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0421
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE1916 mg
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID1000 mg
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize25mm
    FlavorImprint Code L421
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0421-118 in 1 CARTON04/10/2019
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34304/10/2019
    Labeler - Cardinal Health (063997360)

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