Label: DEFENSOL D BLISTER PACK- acetaminophen, diphenhydramine hcl, phenylephrine hci tablet

  • NDC Code(s): 53145-009-30
  • Packager: Menper Distributors, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 22, 2025

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

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)

    Acetaminophen 325 mg

    Diphenhydramine HCl 12.5 mg

    Phenylephrine HCI 5 mg

  • PURPOSE

    Purpose

    Pain Reliever

    Antihistamine/ Cough Suppresant

    Nasal Decongestant

  • INDICATIONS & USAGE

    Uses

    Temporarily relieves these symptoms associated with cold or flu:

    • headache
    • nasal congestion
    • sore throat
    • fever
    • minor aches and pains
    • Temporarily relieves minor aches, pains, and headache as well as those symptoms of hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • nasal congestion
    • itching of the nose or throat
    • itchy, watery eyes

    Temporarily relieves minor aches, pains, headache, and nasal congestion as well as sinus congestion and pressure, and reduces swelling of nasal passages

  • WARNINGS

    Warnings

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

    • more than 8 tablets in any 24-hour period, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Severe throat warning:if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

    Allergy alert: Acetaminophen may cause severe skin reactions:

    • Symptoms may include: skin reddening
    • blisters
    • rash

    if a skin reaction occurs, stop use and seek medical help right away.

  • DO NOT USE

    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

    • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for

    depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after
    stopping the MADI drug. If you do not know if your prescription drug contains MADI, ask a doctor or
    pharmacist befaretakingthisprocluct.
    ■ if you have ever had an allergic reaction to this product or any of its ingredients
    ■ to sedate a child or to make a child sleepy
    ■ with any other product containing diphenhydramine, even one used on skin.

  • ASK DOCTOR

    Ask doctor before use if you have

    • liver desease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland
    • glaucoma
    • a breathing problem such as emphysema, asthma, or chronic bronchitis
    • taking the blood thinning drug warfarin
    • taking any other oral nasal decongestant or stimulant
    • taking any other pain relieve/fever reducer
    • taking sedatives or tranquilizers
  • WHEN USING

    When using this product

    • do not use more than directed
    • 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 in children
  • STOP USE

    Stop use and ask a doctor if

    • you get nervous, dizzy, or sleepless
    • pain or nasal congestion gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    Overdose warning:In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions: do not take more than 12 tablets in a 24 hour period.

    • do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage. This adult product is not intended for use in children under 12 years of age
    age dose
    adults and children 12 years and over 2 tablets every 4 hours
    children under 12 years do not use

  • INACTIVE INGREDIENT

    Inactive ingredients
    corn starch, croscarmellose sodium, crospovidone, FD&C blue#1 aluminum lake, FO&C blue#2 aluminum lake, iron oxide yellow, magnesium stearate, methacrylic acid, and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, s I con dioxide, sodium bicarbonate, stearic acid, talc, titanium oxide.

  • QUESTIONS

    Questions?Menper Distributors, Inc. 1-800-560-5223; M-F 9 AM - 4 PM Eastern

  • PRINCIPAL DISPLAY PANEL

    Pack

  • INGREDIENTS AND APPEARANCE
    DEFENSOL D BLISTER PACK 
    acetaminophen, diphenhydramine hcl, phenylephrine hci tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-009
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    TALC (UNII: 7SEV7J4R1U)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:2) (UNII: XRK36F13ZZ)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    Product Characteristics
    ColorblueScore2 pieces
    ShapeRECTANGLESize10mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53145-009-301 in 1 BOX01/01/2024
    130 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/01/2024
    Labeler - Menper Distributors, Inc. (101947166)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc868734088manufacture(53145-009)