Somnapure Tablet, Coated
FDA Label NDC 69721-005

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Force Factor Brands Llc for the product Somnapure (NDC 69721-005). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)

Box (Box 005)

Box (Box 005)

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