Label: ACETAMINOPHEN tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 December 2, 2019

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

  • SPL UNCLASSIFIED SECTION

    Acetaminophen 325 mg Chewable Gels

    Alexso, Inc.

    ----------------

    Acetaminophen 325 mg Chewable Gels

    DRUG FACTS

  • ACTIVE INGREDIENT

    Acetaminophen 325mg

  • PURPOSE

    Pain reliever/fever reducer

  • USES

    Acetaminophen 325mg Chewable Gel is used for the temporarily relief of minor aches and pain due to the common cold, flu, headache, sore throat, toothache, and temporarily reduces fever.

  • WARNINGS

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if:

    • adult takes more than 4,000 mg of acetaminophen in 24 hours
    • child takes more than 5 doses in 24 hours
    • with other drugs containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a physician or pharmacist.
    • adults has 3 or more alcoholic drinks every day while using this product
    • skin reddening
    • blisters
    • rash

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include

    If a skin reaction occurs, stop use and seek medical help right away.

    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

    • with other drugs containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a physician or pharmacist.
    • if you are allergic to acetaminophen or any of the inactive ingredients in this product.

    Take under the supervision of a physician if you have liver disease, taking a blood thinning drug called warfarin, or have a history of high blood pressure or diabetes.  

    Stop use and ask a doctor if

    • pain gets worse or lasts more than 10 days (for adults) or 5 days (for children)
    • fever gets worse or lasts more than 3 days
    • new symptoms occur
    • redness or swelling is present

    These could be signs of a serious condition.

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

    KEEP OUT OF REACH OF CHILDREN

    Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • DIRECTIONS

    Do not take more than directed (see overdose warning)

    Adults and children 12 years and over:

    • take 2 chewable gels every 4 to 6 hours while symptoms last or as directed by a physician
    • chew each chewable gel thoroughly before swallowing
    • do not take more than 10 chewable gels in 24 hours
    • do not take for more than 10 days unless directed by a physician
    • take 1 chewable gel every 4 to 6 hours while symptoms last or as directed by a physician
    • chew each chewable gel thoroughly before swallowing
    • do not take more than 5 chewable gels in 24 hours
    • do not take for more than 5 days unless directed by a physician

    Children 6 to 11 years:

    Children under 6 years: ask a physician

  • OTHER INFORMATION

    • each chewable gel contains: sodium 7.44 mg.
    • each chewable gel contains: sugar 2g. 
    • store in a cool dry place between 20-25°C (68-77°F).

    Child Resistant Container; do not use if printed seal under cap is broken or missing.

  • Inactive ingredients:

    hydroxypropyl betadex, seaweed extract (carrageenan), maltitol solution, sugar, sodium citrate, sodium chloride, sucralose, neotame, maltodextrin, glucose syrup, flavor, purified water.

  • HOW SUPPLIED

    Acetaminphen 325mg Chewable Gel is supplied in the following dosage form:

    Fourteen (14) chewable gels per container

    Made in USA

    Rx Only

    Manufactured for:

    Alexso, Inc.

    2317 Cotner Ave

    Los Angeles, CA 90064

    NDC: 50488-4325-1

    Size: 14 Chewable Gels

  • PRINCIPAL DISPLAY PANEL

    Acetaminophen 325 mg Chewable Gels
    14 Orange Flavored Gummies
    NDC: 50488-4325-1

    PRINCIPAL DISPLAY PANEL
Acetaminophen 325 mg Chewable Gels
14 Orange Flavored Gummies
NDC: 50488-4325-1

    PRINCIPAL DISPLAY PANEL
Acetaminophen 325 mg Chewable Gels
14 Orange Flavored Gummies
NDC: 50488-4325-1

    PRINCIPAL DISPLAY PANEL
Acetaminophen 325 mg Chewable Gels
14 Orange Flavored Gummies
NDC: 50488-4325-1

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50488-4325
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    MALTITOL (UNII: D65DG142WK)  
    SUCROSE (UNII: C151H8M554)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    NEOTAME (UNII: VJ597D52EX)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeROUNDSize25mm
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50488-4325-114 in 1 CONTAINER; Type 0: Not a Combination Product11/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34311/01/2019
    Labeler - Alexso, Inc (963338061)