Label: ASSURED HEADACHE PM (ASPIRIN FREE)- acetaminophen and diphenhydramine citrate tablet, coated

  • NDC Code(s): 68210-0020-3
  • Packager: Spirit Pharmaceutical LLC
  • 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 10, 2020

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each caplet)Purpose
    Acetaminophen 500 mgPain reliever
    Diphenhydramine citrate 38 mgNighttime sleep-aid
  • Uses

    for the 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 2 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

    Allergy alert

    Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin or general allergic reaction occurs, stop use and seek medical help right away.

    Do not use

    • if you are allergic to acetaminophen
    • 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

    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
    • taking sedatives or tranquilizers

    When using this product

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

    Stop use and ask a doctor if

    • any new symptoms occur
    • sleeplessness lasts continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
    • pain gets worse or lasts more than 10 days
    • painful area is red or swollen
    • fever gets worse or lasts more than 3 days

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

    Keep out of reach of children.

    Overdose warning

    In case of overdose, get medical help or contact a Poison Control Center 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 use more than directed
    • do not use in children under 12 years of age
    • adults and children 12 years of age and over: take 2 caplets at bedtime, if needed, or as directed by a doctor
  • Other information

    • store at controlled room temperature 20°-25°C (68°-77°F)
    • read all product information before using. Keep this box for important information.
  • Inactive ingredients

    colloidal silicon dioxide, FD&C Blue # 1, FD&C blue #2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized corn starch, stearic acid, titanium dioxide

  • Questions or comments?

    1-888-333-9792

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY
    GREENBRIER INTERNATIONAL, INC.
    500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

  • PRINCIPAL DISPLAY PANEL - 20 Caplet Bottle Carton

    ASSURED

    COMPARE TO ACTIVE INGREDIENTS OF
    EXCEDRIN ® PM*

    ASPIRIN FREE

    Headache PM

    • Acetaminophen 500 mg

      Pain Reliever

    • Diphenhydramine Citrate 38 mg

      Nighttime Sleep-Aid

    Actual Size
    NON HABIT FORMING

    20 caplets

    PRINCIPAL DISPLAY PANEL - 20 Caplet Bottle Carton
  • INGREDIENTS AND APPEARANCE
    ASSURED HEADACHE PM (ASPIRIN FREE) 
    acetaminophen and diphenhydramine citrate tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0020
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code S26
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-0020-31 in 1 CARTON08/12/2016
    120 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34308/12/2016
    Labeler - Spirit Pharmaceutical LLC (179621011)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elysium Pharmaceutical Ltd915664486manufacture(68210-0020)