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
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 30, 2020

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)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    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 not finalpart34307/01/2019
    Labeler - Granules USA, Inc. (137098864)