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  5. Label Information: Valumeds Nighttime Sleep Aid

FDA Label for Valumeds Nighttime Sleep Aid

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENTS (IN EACH CAPLET)
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. OTC - ASK DOCTOR/PHARMACIST
    9. WHEN USING THIS PRODUCT
    10. STOP USE AND ASK A DOCTOR IF
    11. OTC - PREGNANCY OR BREAST FEEDING
    12. OTC - KEEP OUT OF REACH OF CHILDREN
    13. OVERDOSE WARNING
    14. DIRECTIONS
    15. OTHER INFORMATION
    16. INACTIVE INGREDIENTS
    17. QUESTIONS OR COMMENTS?
    18. PRINCIPAL DISPLAY PANEL - 36 COUNT BOTTLE CARTON

Valumeds Nighttime Sleep Aid Product Label

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

Other



Drug Facts

Distributed By: Spirit Pharmaceuticals, LLC

Ronkonkoma, NY 11779


Active Ingredients (In Each Caplet)



Diphenhydramine HCl 25mg


Purpose



nighttime sleep-aid


Uses



for the relief of occasional sleeplessness


Warnings



Warnings


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
  • trouble urinating due to an enlarged 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 drinks
  • drowsiness will occur
  • do not drive a 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.


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.


Overdose Warning



In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)


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



each caplet contains: calcium 23.52 mg

store between 20-25°C(68-77°F). Avoid high humidity. Protect from light.


Inactive Ingredients



Colloidal siicon dioxide, croscarmellose sodium, dicalcium phosphate, FD&C Blue#1, FD&C Blue#2, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide


Questions Or Comments?



1-888-333-9792


Principal Display Panel - 36 Count Bottle Carton



VALUMEDS™

Compare to the active ingredient

in TYLENOL® SIMPLY SLEEP®*

NIGHTTIME

SLEEP AID

DIPHENHYDRAMINE HCl 25 mg

NON-HABIT FORMING

DOES NOT CONTAIN PAIN RELIEVER

36 CAPLETS


* Please review the disclaimer below.