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  5. Label Information: Somnapure Clinical Strength

FDA Label for Somnapure Clinical Strength

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - ASK DOCTOR/PHARMACIST
    8. OTC - WHEN USING
    9. OTC - STOP USE
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. DOSAGE & ADMINISTRATION
    13. OTHER SAFETY INFORMATION
    14. INACTIVE INGREDIENT
    15. OTC - QUESTIONS
    16. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Somnapure Clinical Strength Product Label

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

Drug Facts



Active ingredient (in each caplet)

Diphenhydramine HCl 50 mg


Otc - Purpose



Purpose

Nighttime sleep aid


Indications & Usage



Use for relief of occasional sleeplessness


Warnings



Warnings


Otc - Do Not Use



Do not use

  • in 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
  • difficulty in urination due to enlargement of the prostate gland

Otc - Ask Doctor/Pharmacist



Ask a doctor before use if you are taking sedatives, tranquilizers, or any other sleep aid. 


Otc - When Using



When using this product, avoid alcoholic drinks. 


Otc - Stop Use



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


Otc - Pregnancy Or Breast Feeding



If pregnant or breastfeeding, 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. 


Dosage & Administration



Directions

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

Other Safety Information



Other information 

  • store at 15°-30°C (59°-86°F)

Inactive Ingredient



Inactive ingredients  collodial silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, stearic acid


Otc - Questions



Questions of comments?  Call 1-855-606-6507


Package Label.Principal Display Panel



Peak Life

Somnapure® Clinical Strength

Nighttime Sleep Aid / Diphenhydramine HCL

  • Fall Asleep Quickly
  • Wake Up Energized
  • Non-Habit-Forming

    • #1 Doctor-Recommended Ingredient


    30 Sleep Caplets

    One Caplet per Dose

    Distributed by Peak Life, LLC,

    a subsidiary of NutraClick, LLC

    PeakLife.com / 1-855-606-6507

    Boston, MA 02108

    TC - SomnapureCS Carton - SomnapureCS Carton 052115 v2

    TC - SomnapureCS Carton - SomnapureCS Carton 052115 v2


* Please review the disclaimer below.