Home > Drugs A-Z > Acetaminophen and Diphenhydramine HCl

Acetaminophen and Diphenhydramine HCl (Rugby Laboratories Inc.)

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TABLET 50 TABLET in 1 BOTTLE (0536-3479-06) Label Information

Complete Acetaminophen and Diphenhydramine HCl Information

  • Active Ingrdient

    (in each captab)


  • PURPOSE

    Pain Reliever/Sleep Aid


  • Uses

    Temporarily relieves 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 8 captabs in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks everyday while using this product.

    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.
    • with any other drug containing diphenhydramine, even one used on skin
    • in children under 12 years of age

      Ask a doctor before use if you have

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

      Ask a doctor or pharmacist before use if you are.

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers

      When using this product

    • marked drowsiness will occur
    • avoid alcoholic drinks
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • do not drive motor vehicle or operate machinery

      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
    • redness or swelling is present
    • any new symptoms appear
    • sleeplessness lasts more than 2 weeks. Insomnia may be a sign of serious underlying medical illness.

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

      Keep out of children.

      In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.


  • Directions

    adults and children 12 years or over:

    • take 2 captabs at bedtine if needed
    • do not take more than directed

    childrens under 12 years do not use


  • Other Information

    Store at room temperature 15°-30°C (59°-86°F)


  • Inactive Ingredients

    Croscarmellose sodium, FD&C blue #1, hypromellose, microcrystalline cellulose, polyethylene glycol 400, povidone, pregelatinized corn starch, silicon dioxide, stearic acid, titanium dioxide.


  • QUESTIONS

    Call 1-800-645-2158, 9 am – 5 pm ET, Monday – Friday.


  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    C:\Users\advance\Desktop\word docs - rugby\apap-diphenhydramine-50ct\APAP Diphen 500-25 mg Figure 1.png

    C:\Users\advance\Desktop\word docs - rugby\apap-diphenhydramine-50ct\APAP Diphen 500-25 mg Figure 2.png

    50 Captabs Bottle Carton

    NDC 0536-3479-06

    Rugby

    ACETAMINOPHEN 500 mg / Diphenhydramine HCl 25 mg

    Pain Reliever / Sleep Aid

    50 Captabs


  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN AND DIPHENHYDRAMINE HCL 
    acetaminophen and diphenhydramine hcl tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-3479
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color BLUE (light blue) Score no score
    Shape CAPSULE Size 17mm
    Flavor Imprint Code AP;133
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0536-3479-06 50 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 10/06/2010
    Labeler - Rugby Laboratories Inc. (191427277)
    Registrant - Advance Pharmaceutical Inc. (078301063)
    Establishment
    Name Address ID/FEI Business Operations
    Advance Pharmaceutical Inc. 078301063 MANUFACTURE(0536-3479)