GOODYS PM PAIN RELIEVER (ACETAMINOPHEN AND DIPHENHYDRAMINE CITRATE) POWDER [MEDTECH PRODUCTS INC.]

GOODYS PM PAIN RELIEVER (ACETAMINOPHEN AND DIPHENHYDRAMINE CITRATE) POWDER [MEDTECH PRODUCTS INC.]
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NDC 63029-661-01, 63029-661-02
Set ID db5d6c2b-688e-4e88-a42d-0fa2b0d8140b
Category HUMAN OTC DRUG LABEL
Packager Medtech Products Inc.
Generic Name
Product Class
Product Number
Application Number PART341
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    (in each powder)
    Acetaminophen 500 mg
    Diphenhydramine Citrate 38 mg

  • Purposes

    Pain reliever
    Nighttime sleep-aid

  • Uses

    • temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

  • Warnings

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

    • more than 4,000 mg of acetaminophen in 24 hours
    • 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 nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • in children under 12 years of age
    • with any other product containing diphenhydramine, even one used on skin

    Ask a doctor before use if you have

    • liver disease
    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are taking

    • the blood thinning drug warfarin
    • sedatives or tranquilizers

    When using this product

    • drowsiness will occur
    • avoid alcoholic drinks
    • be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.                                                
    • pain gets worse or lasts more than 10 days
    • redness or swelling is present
    • any new symptoms appear
    These could be signs of a serious condition.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    Overdose warning:

    Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact Poison Control Center (1-800-222-1222) right away. 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 of age and over: take 2 powders at bedtime, if needed, or as directed by a doctor. Drink a full glass of water with each dose, or may stir powder into a glass of water or other liquid.
    do not give to children under 12 years of age

  • Other Information

    • each powder contains: potassium 42 mg
    • store below 25°C (77°F)

  • Inactive ingredients

    citric acid, docusate sodium, fumaric acid, glycine, lactose monohydrate, magnesium stearate, potassium chloride, silica gel, sodium benzoate, sodium citrate dihydrate

  • Questions or comments?

    1-866-255-5197 

  • Principal Display Panel

    Goody’s PM
    Acetaminophen • Diphenhydramine Citrate
    Pain Reliever/ Nighttime sleep-aid
    FOR PAIN WITH SLEEPLESSNESS
    16 Powder Packs

    Principal Display Panel
Goody’s PM
Acetaminophen • Diphenhydramine Citrate
Pain Reliever/ Nighttime sleep-aid
FOR PAIN WITH SLEEPLESSNESS
16 Powder Packs

    Principal Display Panel
Goody’s PM
Acetaminophen • Diphenhydramine Citrate
Pain Reliever/ Nighttime sleep-aid
FOR PAIN WITH SLEEPLESSNESS
16 Powder Packs

    Principal Display Panel
Goody’s PM
Acetaminophen • Diphenhydramine Citrate
Pain Reliever/ Nighttime sleep-aid
FOR PAIN WITH SLEEPLESSNESS
16 Powder Packs

    Principal Display Panel
Goody’s PM
Acetaminophen • Diphenhydramine Citrate
Pain Reliever/ Nighttime sleep-aid
FOR PAIN WITH SLEEPLESSNESS
16 Powder Packs

    Principal Display Panel
Goody’s PM
Acetaminophen • Diphenhydramine Citrate
Pain Reliever/ Nighttime sleep-aid
FOR PAIN WITH SLEEPLESSNESS
16 Powder Packs

    Principal Display Panel
Goody’s PM
Acetaminophen • Diphenhydramine Citrate
Pain Reliever/ Nighttime sleep-aid
FOR PAIN WITH SLEEPLESSNESS
16 Powder Packs

  • INGREDIENTS AND APPEARANCE
    GOODYS PM 
    acetaminophen and diphenhydramine citrate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-656
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    DIPHENHYDRAMINE CITRATE (UNII: 4OD433S209) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE CITRATE38 mg
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    FUMARIC ACID (UNII: 88XHZ13131)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    GLYCINE (UNII: TE7660XO1C)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63029-656-066 in 1 CARTON; Type 0: Not a Combination Product09/01/2013
    2NDC:63029-656-1616 in 1 CARTON; Type 0: Not a Combination Product09/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34109/01/2013
    Labeler - Medtech Products Inc. (122715688)

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