PAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DISCOUNT DRUG MART]

PAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DISCOUNT DRUG MART]
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NDC 53943-028-20
Set ID 479c1223-bffd-443a-923f-052adf1b0a2b
Category Human OTC Drug Label
Packager DISCOUNT DRUG MART
Generic Name
Product Class
Product Number
Application Number PART343
  • Drug Facts

    Active ingredients (in each 15 mL)

    Acetaminophen USP 500 mg

    Diphenhydramine HCl USP 25 mg

  • Purpose

    Pain reliever
    Nighttime Sleep Aid

  • Uses

    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 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 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

    • 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
    • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
    • for 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 bronchitis
    • trouble urinating due to an enlarged prostate gland
    • glaucoma
  • Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers or any other sleep aid
  • 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 more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
    • Pain gets worse or lasts more than 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 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.

  • Directions

    • do not take more than directed (see overdose warning)
    • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
    • mL = milliliter
    adults and children 12 years and over
    • take 30 mL at bedtime
    • do not take more than 30 mL in 24 hours
    children under 12 years
    do not use

  • Other information

    • each 15 mL contains: sodium 9 mg
    • store between 20-25°C (68-77°F). Do not refrigerate.
    • don't use if shrink band is missing or broken
    • see back label for lot number and expiration date
  • Inactive ingredients

    anhydrous citric acid, FD&C Blue no.1, FD&C Green no. 3, flavors, high fructose corn syrup, menthol, non-crystallizing sorbitol solution, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium carboxymethylcellulose, and sucralose

  • Questions or comments?

    1-855-274-4122

    DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

    Distributed by:
    Discount Drug Mart
    211 Commerce Drive
    Medina, OH 44256
    www.discount-drugmart.com

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL8 FL OZ (237 mL Bottle)

    NDC 53943-028-20

    DISCOUNT
    drug mart
    FOOD FAIR


    See Warnings Information

    Pain Relief PM

    ACETAMINOPHEN 500 mg - Pain Reliever
    DIPHENHYDRAMINE HCl 25 mg - Nighttime Sleep Aid
    Berry
    (Alcohol free)

    8 FL OZ
    (237 mL)

    Do not use if printed shirkband is missing or broken.

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (237 mL Bottle)

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF PM 
    acetaminophen, diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-028
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg  in 15 mL
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    SORBITOL (UNII: 506T60A25R)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorBLUE (blue to bluish green) Score    
    ShapeSize
    FlavorBERRY, PEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53943-028-201 in 1 CARTON02/23/201607/01/2022
    1237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34302/23/201607/01/2022
    Labeler - DISCOUNT DRUG MART (047741335)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurohealth LLC078728447MANUFACTURE(53943-028)

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