Label: ALKA-SELTZER GOLD 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 May 5, 2017

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

  • Drug Facts

    Drug Facts

  • Active Ingredients

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

    Potassium bicarbonate 344 mg.…..………………….……..Antacid

    Sodium bicarbonate (heat-treated) 1050 mg………………Antacid

  • Purpose

    Antacid

  • INDICATIONS & USAGE

    Uses for the relief of

    ● heartburn ● acid indigestion ● sour stomach

  • Do Not Use

    Do not use if you have ever had an allergic reaction to this product or any of its ingredients

  • Ask a doctor before use if you have

    • kidney disease
    • a potassium or sodium-restricted diet
  • Ask a doctor or pharmacist before use if you are

    Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

  • When using this product

    When using this product do not exceed recommended dosage

  • Stop use and ask a doctor if

    Stop use and ask a doctor if you have taken the maximum dose for 2 weeks

  • PREGNANCY OR BREAST FEEDING

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

  • Keep out of reach of children

    Keep out of reach of children.

  • Directions

    ● fully dissolve tablets in 4 ounces of water before taking

    adults and children 12 years and over2 tablets every 4 hours as needed, or asdirected by a doctordo not exceed8 tablets in 24 hours
    adults 60 years and over2 tablets every 4 hours as needed, or as directed by a doctordo not exceed 6 tablets in 24 hours
    children under 12 years1 tablet every 4 hours as needed, or as directed by a doctordo not exceed 4 tablets in 24 hours

  • Other information

    each tablet contains: potassium 135 mg

    each tablet contains: sodium 309 mg

    ● store at room temperature. Avoid excessive heat.

    ● this product does not contain aspirin

    ● Alka-Seltzer Gold in water contains principally the

    antacids sodium citrate and potassium citrate

  • Inactive ingredients

    Inactive ingredients magnesium stearate, mannitol

  • Questions or comments

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

  • 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

  • PRINCIPAL DISPLAY PANEL

    AS Gold

  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER GOLD 
    alka-seltzer gold tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-4100
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID1000 mg
    POTASSIUM BICARBONATE (UNII: HM5Z15LEBN) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CATION344 mg
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE1050 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize25mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-4100-6318 in 1 CARTON11/19/2014
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33111/19/2014
    Labeler - Bayer HealthCare LLC. (112117283)