1. Home
  2. Labeler Index
  3. Shield Pharmaceuticals Corp
  4. 83059-0122
  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 SOFTGEL)
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. OTC - DO NOT USE
    7. OTC - ASK DOCTOR
    8. OTC - ASK DOCTOR/PHARMACIST
    9. OTC - WHEN USING
    10. OTC - STOP USE
    11. OTC - PREGNANCY OR BREAST FEEDING
    12. OTC - KEEP OUT OF REACH OF CHILDREN
    13. DIRECTIONS
    14. OTHER INFORMATION
    15. INACTIVE INGREDIENTS
    16. QUESTIONS OR COMMENTS?
    17. PRINCIPAL DISPLAY PANEL

Nighttime Sleep Aid Product Label

The following document was submitted to the FDA by the labeler of this product Shield Pharmaceuticals Corp. 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

Distributed by:
Shield Pharmaceuticals Corp.
Ronkonkoma, NY 11779


Active Ingredient (In Each Softgel)



Diphenhydramine HCl 50 mg


Purpose



Nighttime sleep-aid


Uses



• for relief of occasional sleeplessness


Warnings




Otc - Do Not Use



Do not use

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


Otc - Ask Doctor



Ask a doctor before use if you have

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


Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before useif you are taking sedatives or tranquilizers


Otc - When Using



When using this product avoid alcoholic drinks


Otc - Stop Use



Stop use and ask a doctor if
sleeplessness persist continuously for more than 2 weeks. Insomnia may be a symptom of 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 (1-800-222-1222) right away.


Directions



• adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor


Other Information



• store at controlled room temperature 20-25°C (68-77°F)
• protect from light, heat and moisture


Inactive Ingredients



FD&C Blue #1, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide


Questions Or Comments?



1-800-373-6981


Principal Display Panel



Compare to the active ingredient in Unisom® SleepGels

Sleep-Aid

Diphenhydramine HCI Softgels, 50 mg

Label

Label-Front - Label Front

Label-Front - Label Front


* Please review the disclaimer below.