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  5. Label Information: Careall Non-aspirin Pm Extra Strength

FDA Label for Careall Non-aspirin Pm Extra Strength

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. KEEP OUT OF REACH OF CHILDREN
    4. USES
    5. WARNINGS
    6. DIRECTIONS
    7. INACTIVE INGREDIENTS

Careall Non-aspirin Pm Extra Strength Product Label

The following document was submitted to the FDA by the labeler of this product New World Imports, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients



Acetaminophen 500mg

Diphenhydramine HCl 25mg


Purpose



Pain reliever

Nightime sleep aid


Keep Out Of Reach Of Children



Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.  Quick Medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


Uses



Temporarily relieves 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 4000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product.

Allergy Alert:Acetaminophen may cause sever skin reactions.  Symptoms may include: skin reddening, blisters, rash.  If a skin reaction occurs, stop use and seek medical help right away.

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 even 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

        •do not drive a motor vehicle or operate machinery

        •avoid alcoholic drinks

        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 last for more than 10 days.

        •fever gets worse or last for more than 3 days

        •redness or swelling are present

        •new symptoms occur.  These could be signs of a serious condition.

        If pregnant or breast-feeding, ask a health professional before use.


Directions



Do not use more than directed.  (see overdose warning)

Adults and children 12 years of age and older: Take 2 caplets at bedtime.  Do not take more than 2 caplets in 24 hours

Children under 12 years: do not use


Inactive Ingredients



Croscarmellose sodium, FD and C blue #1, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, starch, stearic acid, titanium dioxide, Copovidone K25-31, Lactose, and Magnesium Sterate


* Please review the disclaimer below.