PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [FRED'S, INC.]

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  • PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [FRED'S, INC.]

PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [FRED'S, INC.]
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NDC 55315-557-10
Set ID 77428e30-5987-4ab3-acc9-11e81ab0d1bd
Category HUMAN OTC DRUG LABEL
Packager FRED'S, INC.
Generic Name
Product Class
Product Number
Application Number PART341
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  • Active ingredients (in each gelcap)

    Acetaminophen 500 mg
    Diphenhydramine HCl 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
    • in children under 12 years of age
    • if you are allergic to acetaminophen or any of the inactive ingredients in this product 

    Ask a doctor before use if you have

    • liver disease
    • a breathing problem such as emphysema or chronic bronchitis
    • difficulty in urination due to enlargement of the prostate gland 
    • glaucoma

    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 serious underlying medical illness.
    • new symptoms occur
    • redness or swelling is present
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days

    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.

    In case of accidental 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
    • adults and children 12 years and over
      • take 2 gelcaps at bedtime
      • do not take more than 2 gelcaps of this product in 24 hours
    • children under 12 years: do not use
  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • avoid high humidity
    • see end flap for expiration date and lot number
  • Inactive ingredients

    ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C red #3, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, simethicone, stearic acid, titanium dioxide

  • Principal Display Panel

    fred's®

    Non-habit
    forming
    Actual Size

    Extra Strength
    Pain Reliever PM
    Acetaminophen
    Diphenhydramine HCl
    Pain Reliever/Nighttime Sleep Aid

    40 Rapid Release Gelcaps

    Compare to the
    active ingredients in:
    Extra Strength
    Tylenol® PM    *

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
    SEAL UNDER CAP IS BROKEN OR MISSING

    *This product is not manufactured or distributed by McNeil
    Consumer Healthcare, owner of the registered trademark
    Extra Strength Tylenol® PM.
    50844       REV0615D55610

    DISTRIBUTED BY: fred's, Inc.
    4300 NEW GETWELL RD, MEMPHIS, TN 38118
    www.fredsinc.com

    fred's Promise
    Not Happy With This Product?
    Just Bring It Back For a Refund!

    Freds 44-556

    Freds 44-556

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVER PM  EXTRA STRENGTH
    acetaminophen, diphenhydramine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-557
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    AMMONIA (UNII: 5138Q19F1X)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SHELLAC (UNII: 46N107B71O)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Product Characteristics
    ColorBLUE (light) , BLUE (Dark) Scoreno score
    ShapeOVALSize20mm
    FlavorImprint Code L;6
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55315-557-101 in 1 CARTON12/17/200704/08/2022
    140 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34312/17/200704/08/2022
    Labeler - FRED'S, INC. (005866116)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(55315-557)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088MANUFACTURE(55315-557) , PACK(55315-557)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(55315-557)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(55315-557)
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