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  5. Label Information: Sleep Tabs For Nighttime Use

FDA Label for Sleep Tabs For Nighttime Use

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU
    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. INACTIVE INGREDIENTS
    13. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Sleep Tabs For Nighttime Use Product Label

The following document was submitted to the FDA by the labeler of this product Allegiant Health. 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



Diphenhydramine HCl 25 mg


Purpose



Nighttime sleep aid


Uses



relief of occasional sleeplessness


Do Not Use



with any other products containing diphenhydramine, including one used on skin in children under 12 years of age


Ask A Doctor Before Use If You Have



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


Ask A Doctor Or Pharmacist Before Use If You



are taking sedatives or tranquilizers


When Using This Product



marked drowsiness may occur avoid alcoholic beverages do not drivea motor vehicle or operate machinery


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


If Pregnant Or Breast-Feeding



ask a health professional before use.


Keep Out Of Reach Of Children



In case of accidental overdose, contact a doctor or Poison Control Center immediately


Directions



Adults and children 12 years of age and older

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

Children under 12 years of age

Do not use


Inactive Ingredients



colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide. May contain polyvinyl alcohol, talc.


Package/Label Principal Display Panel



Health A2Z

Sleep Tabs
For Nighttime Use

Diphenhydramine HCl
25 mg

Does not contain Pain Reliever
Safe, non-habit-forming

24 Tablets


* Please review the disclaimer below.