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care one pain relief pm

American Sales Company

American Sales Company Pain Relief PM Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each gelcap)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Purpose

Pain reliever

Nighttime sleep-aid

care one pain relief pm 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 other 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.

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 Liver warning)
take 2 gelcaps at bedtime
  • do not take more than 2 gelcaps of this product in 24 hours

    adults and children 12 years and over

    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

    Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, D&C red #28, D&C yellow #10, edible ink, FD&C blue #1, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, titanium dioxide, triacetin

    Questions or comments?

    1-800-719-9260

    Package/Label Principal Display Panel

    Compare to the Active Ingredients in Tylenol® PM Rapid Release Gels

    PAIN RELIEF PM

    EXTRA STRENGTH

    PAIN RELIEVER/NIGHTTIME SLEEP-AID

    Acetaminophen/Diphenhydramine HCl

    Rapid RELEASE Gelcaps

    Actual Size

    care one pain relief pm

    Acetaminophen, Diphenhydramine HCl CAPSULE, COATED

    Product Information

    Product Type Human otc drug label Item Code (Source) NDC:41520-829
    Route of Administration ORAL DEA Schedule

    Active Ingredient/Active Moiety

    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN ACETAMINOPHEN 500 mg
    DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 25 mg

    Inactive Ingredients

    Ingredient Name Strength
    SILICON DIOXIDE
    CROSCARMELLOSE SODIUM
    D&C RED NO. 28
    D&C YELLOW NO. 10
    FD&C BLUE NO. 1
    FD&C RED NO. 40
    GELATIN
    HYDROXYPROPYL CELLULOSE (TYPE H)
    HYPROMELLOSES
    cellulose, microcrystalline
    POVIDONES
    STEARIC ACID
    titanium dioxide
    triacetin
    FD&C BLUE NO. 2
    FD&C YELLOW NO. 6

    Product Characteristics

    Color Size Imprint Code Shape
    BLUE (Light Blue Opaque) 22 mm L829 CAPSULE

    Packaging

    # Item Code Package Description Marketing Start Date Marketing End Date
    1 20 in 1 BOTTLE
    2 80 in 1 BOTTLE
    3 NDC:41520-829-27 1 in 1 CARTON

    Marketing Information

    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    part part338 2010-09-03


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    Be sure to consult your doctor before taking any medication!
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