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Acetaminophen, Diphenhydramine Hydrochloride (AAA Pharmaceutical, Inc.)

Available Formats

Dosage Form Package Information Links
TABLET, COATED 4 BLISTER PACK in 1 CARTON (57344-101-05) > 12 TABLET, COATED in 1 BLISTER PACK Label Information
TABLET, COATED 2 BLISTER PACK in 1 CARTON (57344-101-01) > 12 TABLET, COATED in 1 BLISTER PACK Label Information

Complete Acetaminophen, Diphenhydramine Hydrochloride Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients
    (in each caplet)    		 Purpose
    Acetaminophen 500 mg Pain reliever
    Diphenhydramine HCl 12.5 mg Antihistamine
  • Uses

    • temporarily relieves:
      • runny nose
      • sneezing
      • itching of the nose or throat and itchy, watery eyes due to hay fever
      • headache
      • minor aches and pains
  • Warnings

    Liver warning

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

    • more than 8 caplets 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

    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 product containing diphenhydramine, even one used on skin

    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 sedatives or tranquilizers
    • taking the blood thinning drug warfarin

    When using this product
    • marked drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

    Stop use and ask a doctor if
    • new symptoms occur
    • redness or swelling is present
    • pain gets worse or lasts for more than 10 days
    • fever gets worse or lasts for more than 3 days

    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 (overdose) may cause liver damage. 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

    adults and children 12 years and over
    • take 2 caplets every 6 hours
    • do not take more than 8 caplets in 24 hours
    children under 12 years
    • do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
  • Other information

    • store between 20º-25ºC (68º-77ºF) in a dry place
    • retain carton for complete product information
  • Inactive ingredients

    colloidal silicon dioxide, copovidone, croscarmellose sodium, D&C yellow #10, FD&C yellow #6, hypromellose, lactose anhydrous, magnesium stearate, methylparaben, povidone, pregelatinized starch, propylene glycol, propylparaben, sodium starch glycolate, stearic acid, titanium dioxide, triacetin

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    AAA Pharmaceutical, Inc.
    681 Main Street
    Lumberton, NJ 08048

  • PRINCIPAL DISPLAY PANEL - 24 Caplet Blister Pack Carton

    NDC 57344-101-01

    RESTORE u

    †COMPARE TO THE ACTIVE
    INGREDIENTS IN TYLENOL®
    SEVERE ALLERGY

    MAY CAUSE
    DROWSINESS

    Severe
    Allergy
    Pain Reliever, Antihistamine

    • Runny Nose
    • Sneezing
    • Itchy, Watery Eyes
      Diphenhydramine HCl
    • Sinus Pain - Acetaminophen

    24 CAPLETS

    PRINCIPAL DISPLAY PANEL - 24 Caplet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE 
    acetaminophen and diphenhydramine hydrochloride tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:57344-101
    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 12.5 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POVIDONES (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    Color YELLOW Score no score
    Shape OVAL Size 17mm
    Flavor Imprint Code AAA;1094
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57344-101-01 2 in 1 CARTON
    1 12 in 1 BLISTER PACK
    2 NDC:57344-101-05 4 in 1 CARTON
    2 12 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 12/22/2012
    Labeler - AAA Pharmaceutical, Inc. (181192162)
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