Somnapure Clinical Strength

Somnapure Clinical Strength
SPL v1
SPL
SPL Set ID cddfdbdd-e6d0-49ef-88e7-b5827c665140
Route
ORAL
Published
Effective Date 2015-04-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg)
Inactive Ingredients
Croscarmellose Sodium Calcium Phosphate, Dibasic, Anhydrous Fd&c Blue No. 1 Fd&c Blue No. 2 Medium-chain Triglycerides Hypromelloses Magnesium Stearate Maltodextrin Cellulose, Microcrystalline Polydextrose Silicon Dioxide Starch, Corn Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-04-09
Description

Active ingredient (in each caplet) Diphenhydramine HCl 50 mg

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Use  for relief of occasional sleeplessness

Dosage and 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

Description

Active ingredient (in each caplet) Diphenhydramine HCl 50 mg

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away. 

Section 50566-9

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. 

Section 50567-7

When using this product, avoid alcoholic drinks. 

Section 50568-5

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

Section 50569-3

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
Section 50570-1

Do not use

  • in children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Section 51727-6

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

Section 51945-4

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

Section 53413-1

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

Section 53414-9

If pregnant or breastfeeding, ask a health professional before use. 

Section 55105-1

Purpose

Nighttime sleep aid

Section 60561-8

Other information

  • store at 15°-30°C (59°-86°F)
drug Facts

Active ingredient (in each caplet)

Diphenhydramine HCl 50 mg

Structured Label Content

Indications and Usage (34067-9)

Use  for relief of occasional sleeplessness

Dosage and Administration (34068-7)

Directions

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

Warnings and Precautions (34071-1)

Warnings

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away. 

Section 50566-9 (50566-9)

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. 

Section 50567-7 (50567-7)

When using this product, avoid alcoholic drinks. 

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

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
Section 50570-1 (50570-1)

Do not use

  • in children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

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

Section 53413-1 (53413-1)

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

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use. 

Section 55105-1 (55105-1)

Purpose

Nighttime sleep aid

Section 60561-8 (60561-8)

Other information

  • store at 15°-30°C (59°-86°F)
drug Facts (Drug Facts)

Active ingredient (in each caplet)

Diphenhydramine HCl 50 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:55.575576 · Updated: 2026-03-14T22:53:59.046955