Label: ACETAMINOPHEN DIPHENHYDRAMINE HCL tablet

  • NDC Code(s): 69848-014-02, 69848-014-05, 69848-014-15
  • Packager: Granules USA, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 16, 2024

If you are a consumer or patient please visit this version.

  • Active ingridients

    (in each caplet)

    Acetaminophen, USP 500mg

    Diphenhydramine HCl. 25mg

  • Purposes

    Pain reliever

    Nighttime sleep-aid

  • Uses

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

  • Liver warning

    This product containsacetaminophen. 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 severs skin reactions. Symptoms may include:
    ■ skin reddening ■ blisters ■ rash
    If a skin reaction occurs, stop use and seek medical help right away

  • DSo 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
    ■ in children under 12 years of age
    ■ if you have ever had an allergic reaction to this product or any of its ingredients

  • Ask a doctor before use if you have

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

  • Ask a doctor or pharmacist before use if you have

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

  • When using this product

    ■ drowsiness will occur
    ■ avoid alcoholic drinks
    ■ do not drive a motor vehicle or operate machinery

  • Stop use and ask a doctor if

    ■ sleeplessness persists continuously for morethan 2 weeks. Insomnia may be a symptom of a serious underlying medical illness
    ■ pain gets worse or lasts more t han 10 days
    ■ fever gets worse or lasts more than 3 days
    ■ redness or swelling is present
    ■ new symptoms occur
    These could be signs of a serious condition.

  • If pregnant or breast-feeding

    ask a health professional before use.

  • Keep out of the reach of chlidren.

  • Overdose warning

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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

    ■ do not take more than directed (see overdose warning)

    adults andchildren 12 years and over

    ■ take 2 caplets at bedtime do not use
    ■ do not take more than 2 caplets of this product in 24 hours

    children under 12 years

    ■ do not use

  • Other information

    ■ store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature.
    ■ see end panel for expiration date and lot number

  • Inactive ingridients

    carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, polysorbate, povidone,pregelatinized starch, stearic acid, titanium dioxide

  • Questions or comments?

  • PRINCIPAL DISPLAY PANEL

    20 count150 count

    50 count

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN DIPHENHYDRAMINE HCL 
    acetaminophen diphenhydramine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69848-014
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVAL (CAPLET SHAPED TABLET) Size17mm
    FlavorImprint Code G;651
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69848-014-0220 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2019
    2NDC:69848-014-0550 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2019
    3NDC:69848-014-15150 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01307/01/2019
    Labeler - Granules USA, Inc. (137098864)