Care One Pain Relief and Pain Relief PM description, usages, side effects, indications, overdosage, supplying and lots more!

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Care One Pain Relief and Pain Relief PM

American Sales Company

American Sales Company Pain Relief and Pain Relief PM Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each caplet) (For Pain Relief)

Acetaminophen 500 mg

Active ingredient (in each caplet) (For Pain Relief PM)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Purpose (For Pain Relief)

Pain reliever/fever reducer

Purpose (For Pain Relief PM)

Pain reliever

Nighttime sleep aid

Uses (For Pain Relief)

  • temporarily relieves minor aches and pains due to:
  • the common cold
  • headache
  • backache
  • minor pain of arthritis
  • toothache
  • muscular aches
  • premenstrual and menstrual cramps
  • temporarily reduces fever

Uses (For Pain Relief PM)

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

Warnings (For Pain Relief)

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3,000 mg) in 24 hours. 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.
  • 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

Ask a doctor or pharmacist before use if you are 

taking the blood thinning drug warfarin

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

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.

Warnings (For Pain Relief PM)

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
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

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 (For Pain Relief)

  • do not take more than directed (see Liver warning) Adults and children 12 years and over:
  • take 2 caplets every 6 hours while symptoms last
  • do not take more than 6 caplets in 24 hours, unless directed by a doctor

    Children under 12 years: ask a doctor

Directions (For Pain Relief PM)

  • do not use more than directed (see Liver 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 (For Pain Relief and Pain Relief PM)

  • store at 20°-25°C (68°-77°F)

Inactive ingredients (For Pain Relief)

carnauba wax*, corn starch*, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid *may contain one or more of these ingredients

Inactive ingredients (For Pain Relief PM)

carnauba wax, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments? (For Pain Relief and Pain Relief PM)

1-800-719-9260

Principal Display Panel

Compare to the Active Ingredient in Tylenol®

PAIN RELIEF

EXTRA STRENGTH

Acetaminophen

PAIN RELIEVER - FEVER REDUCER

Actual Size

See New Warnings and Directions

500 mg Each

VALUE PACK - DAY & NIGHT RELIEF

Compare to the Active Ingredients in Tylenol® PM

Extra Strength

PAIN RELIEF PM

PAIN RELIEVER - NIGHTTIME SLEEP-AID

Acetaminophen

Diphenhydramine HCl

Actual Size

Care One Pain Relief and Pain Relief PM
Pain Relief and Pain Relief PM Carton Image 1 Pain Relief and Pain Relief PM Carton Image 2

Care One Pain Relief and Pain Relief PM

Acetaminophen, Diphenhydramine HCl KIT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:41520-969
Route of Administration DEA Schedule

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41520-969-09 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part338 2006-09-30


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