Somnapure
FDA Label NDC 69721-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nutraclick, Llc for the product Somnapure (NDC 69721-001). 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 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 croscarmellose sodium, dicalcium phosphate, FD&C blue no. 1 lake, FD&C blue no. 2 lake, fractionated coconut oil, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polydextrose, silicon dioxide, starch, stearic acid, talc titanium dioxide

Otc - Questions

Questions or comments? Call 1-877-869-3304

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 / 1-877-869-3304

    Boston, MA 02108

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