Label: GENEXA CHILDRENS ACETAMINOPHEN- 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 September 12, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Acetaminophen 80 mg

  • PURPOSE

    Purpose

    Pain reliever/fever reducer

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves minor aches and pains due to:
    • the common cold
    • sore throat
    • flu
    • toothache
    • headache
    • temporarily reduces fever
  • WARNINGS

    Warnings

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

    • more than 5 doses in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen

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

    • skin reddening
    • blisters
    • rash

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

    Ask a doctor before use if your child has liver disease

    Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

    When using this product do not exceed recommended dose (see Overdose warning)

    Stop use and ask a doctor if

    • pain gets worse or lasts more than 5 days
    • 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.

    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). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions

    • this product does not contain directions or complete warnings for adult use.
    • do not give more than directed (see Overdose warning)
    • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
    • chew tablets completely before swallowing; do not swallow tablets whole
    • repeat dose every 4 hours while symptoms last
    • do not give more than 5 times in 24 hours
    WeightAgeDose †
    Under 24 lbs.Under 2 yearsAsk a doctor
    24-35 lbs.2-3 years2 tablets
    36-47 lbs.4-5 years3 tablets
    48-59 lbs.6-8 years4 tablets
    60-71 lbs.9-10 years5 tablets
    72-95 lbs.11 years6 tablets

    †or as directed by a doctor

  • OTHER SAFETY INFORMATION

    Other information

    • each tablet contains: calcium 10 mg
    • store between 20-25°C (68-77°F). Avoid high humidity. Protect from light.
  • INACTIVE INGREDIENT

    Inactive ingredients

    acacia gum‡, calcium carbonate‡, organic carnauba wax, cellulose‡, citric acid‡, dextrose‡, dibehenin (vegetable source)‡, flavor‡, glycerin‡, grape flavor‡, organic guar gum, maltodextrin‡, organic palm olein, organic stevia rebaudiana leaf extract, organic

    sunflower lecithin, xylitol‡

    ‡ natural

  • QUESTIONS

    Questions? 1-855-436-3921

  • SPL UNCLASSIFIED SECTION

    Carton and bottle are safety sealed. DO NOT use if seal on top and/or bottom of carton or under cap of bottle is disturbed or missing.

    *This product is not manufactured or distributed by Johnson & Johnson Inc., owner of the registered trademark Children's Tylenol® Chewables Grape.

    Patent Pending | Distributed by: Genexa Inc.

    Atlanta, GA 30318 | genexa.com

    Made in the USA with globally sourced ingredients

    R-20211230

    NDC 69676-0058-7

  • PRINCIPAL DISPLAY PANEL

    Children's

    Genexa®

    MEDICINE MADE CLEAN

    Ages 2-11

    Acetaminophen Chewables

    Pain Reliever Fever Reducer

    How we're different

    Made without: crospovidone, D&C red no. 30 aluminum lake, sucralose & more!

    Read our label vs. Children'sTylenol® Chewables Grape*

    24 Chewable Tablets

    80 mg each

    Grape Flavor

    10000-GNX_Kids-Pain-Fever_Chewable_Carton_2022_05_26 Approved

  • INGREDIENTS AND APPEARANCE
    GENEXA CHILDRENS ACETAMINOPHEN 
    acetaminophen tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69676-0058
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN80 mg
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    PALM OIL (UNII: 5QUO05548Z)  
    XYLITOL (UNII: VCQ006KQ1E)  
    GUAR GUM (UNII: E89I1637KE)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    ACACIA (UNII: 5C5403N26O)  
    Product Characteristics
    Colorwhite (LIGHT BEIGE WITH SPECKLES) Scoreno score
    ShapeROUNDSize20mm
    FlavorGRAPEImprint Code G10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69676-0058-71 in 1 CARTON02/28/2022
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34302/28/2022
    Labeler - Genexa Inc. (079751024)
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