GOODYS BACK AND BODY (ACETAMINOPHEN) LIQUID [MEDTECH PRODUCTS INC.]

GOODYS BACK AND BODY (ACETAMINOPHEN) LIQUID [MEDTECH PRODUCTS INC.]
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NDC 63029-620-02, 63029-620-04
Set ID 25c8b94d-84aa-4164-824f-7a52490808b8
Category HUMAN OTC DRUG LABEL
Packager Medtech Products Inc.
Generic Name
Product Class
Product Number
Application Number PART343
  • SPL UNCLASSIFIED SECTION

    Goody’s®
    Back & Body Pain Relief

    1000 mg Acetaminophen
    PAIN RELIEVER/ FEVER REDUCER

    SINGLE DOSE
    2 FL OZ (60 mL)

    Drug Facts

  • Active ingredient (per 60 mL)

    Acetaminophen 1000 mg

  • Purpose

    Pain reliever/ Fever reducer

  • Use

    Temporarily relieves minor aches and pains due to:

    • headache
    • muscle aches
    • cold and flu
    • toothache
    • minor arthritis pain
    • back ache

    Temporarily reduces fever.

  • Warnings

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

    you take

    • more than 3 full (60 mL) bottles in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    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.

    Do not use

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

    Ask a doctor before use if you have

    liver disease.

    Ask a doctor or pharmacist before use if

    you are taking the blood thinning drug warfarin.

    Stop use and ask a doctor if

    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • new symptoms occur
    • redness or swelling is present

    If pregnant or breastfeeding,

    ask a healthcare professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical 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 of age and over: take one full (60 mL) bottle every 6 hours while symptoms persist; do not take more than 3 full (60 mL) bottles in 24 hours.
    • children under 12 years of age: ask a doctor
  • Other information

    • store at room temperature
    • read all product information before using
  • Inactive ingredients

    citric acid, flavor, glycerin, polyvinylpyrrolidone, potassium citrate, potassium sorbate, propylene glycol, purified water, sucralose

    Questions?

    1-866-255-5197 goodyspowder.com

    Tamper Evident: Do not use if printed shrink band on bottle is broken or missing.

    ©2015 Distributed by Medtech Products Inc.
    Tarrytown, NY 10591, a Prestige Brands Company

  • PRINCIPAL DISPLAY PANEL

    Goody’s
    Back & Body
    Pain Relief
    1,000 MG Acetaminophen
    Pain Reliever/ Fever Reducer
    2 FL OZ (60 mL)

    PRINCIPAL DISPLAY PANEL
Goody’s
Back & Body
Pain Relief
1,000 MG Acetaminophen
Pain Reliever/ Fever Reducer
2 FL OZ (60 mL)

    PRINCIPAL DISPLAY PANEL
Goody’s
Back & Body
Pain Relief
1,000 MG Acetaminophen
Pain Reliever/ Fever Reducer
2 FL OZ (60 mL)

  • INGREDIENTS AND APPEARANCE
    GOODYS  BACK AND BODY
    acetaminophen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-620
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN1000 mg  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POVIDONE K29/32 (UNII: 390RMW2PEQ)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63029-620-021 in 1 CARTON08/01/2015
    160 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:63029-620-042 in 1 CARTON08/01/2015
    260 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34308/01/2015
    Labeler - Medtech Products Inc. (122715688)

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