EXTRA STRENGTH NO-PAIN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [SAFREL PHARMACEUTICALS, LLC.]

EXTRA STRENGTH NO-PAIN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [SAFREL PHARMACEUTICALS, LLC.]
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NDC 71309-006-02, 71309-006-05, 71309-006-10, 71309-006-25, 71309-006-30, 71309-006-50
Set ID 87655c3e-acab-bdc2-e053-2a95a90ae2a1
Category HUMAN OTC DRUG LABEL
Packager Safrel Pharmaceuticals, LLC.
Generic Name
Product Class
Product Number
Application Number PART343
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each caplet) Purpose
    Acetaminophen 500 mgPain reliever
    Diphenhydramine HCl 25 mgNighttime 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

    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 product containing diphenhydramine, even one used on skin 
    • in 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

    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)
    • 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 this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
  • Other information

    • store between 20-25°C (68-77°F)
    • do not use if pouch is torn or open
    • see side panel for lot number and expiration date
  • Inactive ingredients

    colloidal silicon dioxide, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake,
    magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol,
    povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

    Questions or comments?

    1-844-384-3723 (Mon-Fri 9am-5pm EST) or www.safrelpharma.com

  • PRINCIPAL DISPLAY PANEL


    Compare to the Active Ingredients in
    Tylenol PM
    ®*

    Pain Relief PM

    Pain RelieverNighttime Sleep Aid

    Acetaminophen, Diphenhydramine HCl

    apap pm

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH NO-PAIN PM 
    acetaminophen and diphenhydramine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71309-006
    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
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code 131
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71309-006-2525 in 1 BOX06/06/2016
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:71309-006-5050 in 1 BOX06/06/2016
    22 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:71309-006-022 in 1 POUCH06/06/2016
    32 in 1 POUCH; Type 0: Not a Combination Product
    4NDC:71309-006-37375 in 1 BOTTLE06/06/2016
    4NDC:71309-006-05500 in 1 BOTTLE
    4NDC:71309-006-3030 in 1 BOTTLE
    41 in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34302/09/2016
    Labeler - Safrel Pharmaceuticals, LLC. (080566287)

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