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  5. Label Information: Rexall Sleep Aid

FDA Label for Rexall Sleep Aid

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH CAPLET)
    2. PURPOSE
    3. USE
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. IF PREGNANT OR BREAST-FEEDING,
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. PRINCIPAL DISPLAY PANEL

Rexall Sleep Aid Product Label

The following document was submitted to the FDA by the labeler of this product Dolgencorp, 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.

Active Ingredient (In Each Caplet)



Diphenhydramine HCl 25 mg


Purpose



Nighttime sleep-aid


Use



for relief of occasional sleeplessness


Do Not Use



  • •in children under 12 years of age
  • •with any other product containing diphenhydramine, even one used on skin

Ask A Doctor Before Use If You Have



  • •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 sedatives or tranquilizers


When Using This Product



avoid alcoholic drinks


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.


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.


Directions



adults and children 12 years and over

take 2 caplets at bedtime if needed, or as directed by a doctor

children under 12 years

do not use


Other Information



  • •store at 20°-25°C (68°-77°F)

Inactive Ingredients



crospovidone, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide


Principal Display Panel



Sleep-Aid

Non-habit forming

For a restful night’s sleep

Contains no pain reliever

Nighttime Sleep-Aid

Diphenhydramine Hydrochloride

100 Rapid Release Caplets

GLUTEN FREE


* Please review the disclaimer below.