Label: COUNTERACT PM- acetaminophen and diphenhydramine tablet

  • NDC Code(s): 54473-304-01, 54473-304-50
  • Packager: Melaleuca, 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 January 18, 2019

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  • Active ingredients

    Acetaminophen 500 mg

    Diphenhydramine HCl 25 mg

  • 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
    • in children under 12 years of age
    • if you are allergic to acetaminophen or any of the ingredients in this product
  • Warnings

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

    • more than 4,000 mg of acetaminophen in 24 hours, which is the maimum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product
  • Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers
  • When using this product

    • drowsiness will occur
    • avoid alcoholic beverages
    • do not drive a motor vehicle or operate machinery
  • Stop use and ask a doctor if

    • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a searious underlying medical illness.
    • new symptoms occur
    • redness or swelling is present
    • pain gets worse of lasts more than 10 days
    • fever gets worse or lasts more than 3 days

    These could be signs of a serious condition

  • WARNINGS

    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.

    Keep out of reach of children

  • Purpose

    Pain reliever

    Nighttime sleep-aid

  • Directions

    do not take more than directed (see overdose warning)
    adults and children 12 years and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours.
    children under 12 years: do not use.

  • Other Information

    • store at controlled room temperature 15-30 oC (59-86 oF)
    • see end flap for expiration date and lot number
  • Questions or comments?

    If you have any questions or comments, or to report an adverse even, please contact 1-800-282-3000.

  • Inactive ingredients

    calcium carbonate, corn starch, citric acid, croscarmellose sodium, hypromellose, lactose, magnesium silicate,

    magnesium stearate, maltodextrin, microcrystalline cellulose, medium-chain triglyceride, polyvinylpyrrolidone, pregelatinized starch, silicon dioxide, sodium carbonate, sodium starch glycolate, stearic acid.

  • Do not take this product unless directed by a doctor if you have

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

    temporary relief of occassional headaches, minor aches, and pains with accompanying sleeplessness

  • PRINCIPAL DISPLAY PANEL

    BottleBox

  • INGREDIENTS AND APPEARANCE
    COUNTERACT  PM
    acetaminophen and diphenhydramine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-304
    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
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    PYRROLIDONE (UNII: KKL5D39EOL)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorwhite (no color added) Scoreno score
    ShapeCAPSULE (Caplet) Size18mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54473-304-011 in 1 BOX05/02/2016
    1NDC:54473-304-5050 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34305/02/2016
    Labeler - Melaleuca, Inc. (139760102)
    Registrant - Melaleuca, Inc. (139760102)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advance Pharmaceutical078301063manufacture(54473-304)
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