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  5. Label Information: Excinol Night (acetaminophen)

FDA Label for Excinol Night (acetaminophen)

View Indications, Usage & Precautions

Table of Contents

    1. EXCINOL NIGHT (ACETAMINOPHEN)500 MG
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENTS
    10. QUESTIONS OR COMMENTS?

Excinol Night (acetaminophen) Product Label

The following document was submitted to the FDA by the labeler of this product America Medic & Science, Llc. 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.

Excinol Night (Acetaminophen)500 Mg



Drug Facts


Active Ingredient



Acetaminophen 500 mg

Diphenhydramine HCl 25 mg


Purpose



Pain reliever

Night time sleep aid


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.

Directions



do not take more than directed (see overdose 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



  • store between 20-25°C (68-77°F)
  • do not use if neck wrap is broken or missing
  • see end panel for lot number and expiration date

Inactive Ingredients



Carnauba wax, FD&C blue# 1 al lake, FD&C blue# 2 al lake, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, titanium dioxide, triacetin.


Questions Or Comments?



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