1. Home
  2. Labeler Index
  3. Force Factor Brands Llc
  4. 69721-005
  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. PRINCIPAL DISPLAY PANEL

Somnapure Clinical Strength Product Label

The following document was submitted to the FDA by the labeler of this product Force Factor Brands 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 

helps to reduce difficulty in falling asleep


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 or pharmacist before use if you are taking sedatives or tranquilizers.


Otc - When Using



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 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 (1-800-222-1222)  right away. 


Dosage & Administration



Directions

  • adults and children 12 years and over: take 1 caplet at bedtime if needed or as directed by a doctor
  • Children under 12 years: do not use.

Other Safety Information



Other information 

  • each caplet contains: calcium 50 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number.
  • protect from moisture

Inactive Ingredient



Inactive ingredients  croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silcon dioxide, stearic acid, talc, titanium dioxide, yellow iron oxide 


Otc - Questions



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


Principal Display Panel



Force Factor Somnapure

Clinical Strength

Nighttime Sleep Aid / Diphenhydramine HCl

#1 Doctor-Recommended Ingredient

Fall Asleep Quickly
Wake Up Energized
Non-Habit-Forming

30 Caplets

One Caplet per Dose

label - Label 005

label - Label 005


* Please review the disclaimer below.