Label: SOHMED PAIN RELIEF PM- acetaminophen and diphenhydramine hydrochloride tablet 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 08/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients (in each caplet) Purpose
    Acetaminophen 500 mg Pain reliever
    Diphenhydramine HCl 25 mg Nighttime sleep aid
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  • Uses

    temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

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  • 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 everyday while using this product

    Although rare, possible reactions to consumption of acetaminophen include three serious skin diseases whose symptoms can include rash, blisters and, in the worst case, widespread damage to the surface of the skin. If you are taking this product and develop a rash or other skin reaction, stop taking this product immediately and seek medical attention.

    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 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 or 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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  • Directions

    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.
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  • Other information

    • Store between 20°-25°C (68°-77°F)
    • See end flap for expiration date and lot number
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  • Inactive ingredients

    carnauba wax, FD&C blue #1 aluminium lake, FD&C blue #2 aluminium lake, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium citrate, sodium starch glycolate, titanium dioxide

    Contains No Aspirin

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  • Question or comments?

    1(856) 2863646

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  • SPL UNCLASSIFIED SECTION

    Distributed by : Sohm, Inc.
    6920 Knott Ave., Suit A-C
    Buena Park, CA 90621

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  • PRINCIPAL DISPLAY PANEL - 24 Caplet Bottle Carton

    SohMed

    NDC XXXXXXXXXX

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

    Extra Strength

    Pain Relief PM

    Acetaminophen 500 mg, Diphenhydramine HCl 25 mg

    Pain Reliever / Nighttime Sleep aid

    24 Caplets

    Non-Habit
    Forming

    Principal Display Panel - 24 Caplet Bottle Carton
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  • INGREDIENTS AND APPEARANCE
    SOHMED PAIN RELIEF PM 
    acetaminophen and diphenhydramine hydrochloride tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50405-007
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Acetaminophen (Acetaminophen) Acetaminophen 500 mg
    Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine Hydrochloride 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    CARNAUBA WAX  
    FD&C Blue No. 1  
    FD&C Blue No. 2  
    aluminum oxide  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    POLYETHYLENE GLYCOL 6000  
    POLYSORBATE 80  
    POWDERED CELLULOSE  
    PROPYLENE GLYCOL  
    STARCH, CORN  
    SHELLAC  
    SODIUM CITRATE  
    SODIUM STARCH GLYCOLATE TYPE A CORN  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color BLUE Score 2 pieces
    Shape OVAL Size 18mm
    Flavor Imprint Code CRX
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50405-007-24 1 in 1 CARTON
    1 24 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 08/25/2013
    Labeler - SOHM Inc. (009303848)
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