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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 geltab)

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 lasts 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 geltabs at bedtime
  • do not take more than 2 geltabs 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

    crospovidone, D&C red #33 aluminum lake, edetate disodium, edible ink, FD&C blue #1 aluminum lake, gelatin, glycerin, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

    Package/Label Principal Display Panel

    Compare to the Active Ingredients in Tylenol® PM

    EXTRA STRENGTH

    PAIN RELIEF PM

    PAIN RELIEVER • NIGHTTIME SLEEP-AID

    Acetaminophen

    Diphenhydramine HCl

    care one pain relief pm

    Acetaminophen, Diphenhydramine HCl TABLET, COATED

    Product Information

    Product Type Human otc drug label Item Code (Source) NDC:41520-837
    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
    CROSPOVIDONE
    D&C RED NO. 33
    EDETATE DISODIUM
    FD&C BLUE NO. 1
    GELATIN
    GLYCERIN
    HYPROMELLOSES
    MAGNESIUM STEARATE
    cellulose, microcrystalline
    POVIDONES
    STEARIC ACID
    titanium dioxide
    POLYETHYLENE GLYCOLS

    Product Characteristics

    Color Size Imprint Code Shape
    WHITE 12 mm L837 ROUND

    Packaging

    # Item Code Package Description Marketing Start Date Marketing End Date
    1 50 in 1 BOTTLE
    2 NDC:41520-837-71 1 in 1 CARTON

    Marketing Information

    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    part part338 2004-04-13


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    Be sure to consult your doctor before taking any medication!
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