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  5. Label Information: Nighttime Sleep Aid

FDA Label for Nighttime Sleep Aid

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH 30 ML DOSE CUP)
    3. PURPOSE
    4. USES
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. OTC - ASK DOCTOR/PHARMACIST
    8. WHEN USING THIS PRODUCT
    9. OTC - STOP USE
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. PRINCIPAL DISPLAY PANEL - 354 ML LABEL

Nighttime Sleep Aid Product Label

The following document was submitted to the FDA by the labeler of this product Walgreen Company. 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.

Other



Drug Facts


Purpose



Nighttime sleep-aid


Uses



  • ▪for the relief of occasional sleeplessness
  • ▪reduces time to fall asleep if you have difficulty falling asleep

Do Not Use



  • ▪for 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
  • ▪glaucoma
  • ▪difficulty in urination due to enlargement of the prostate gland

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers


When Using This Product



  • ▪avoid alcoholic beverages

Otc - Stop Use



Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.


Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222


Directions



  • ▪take only one dose per day (24 hours)
  • ▪only use the dose cup provided

    • adults & children 12 yrs & over

    30 mL at bed time if needed or as directed by a doctor

    children under 12 yrs

    do not use


Inactive Ingredients



anhydrous citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose.


Questions Or Comments?



1-866-467-2748


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