Somnapure Clinical Strength 

Somnapure Clinical Strength 
SPL v1
SPL
SPL Set ID 13e2660d-d0a2-4d57-b2de-4c41257ccf83
Route
ORAL
Published
Effective Date 2018-03-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg)
Inactive Ingredients
Croscarmellose Sodium Dibasic Calcium Phosphate Dihydrate Fd&c Blue No. 1 Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycols Polyvinyl Alcohol, Unspecified Silicon Dioxide Stearic Acid Talc Titanium Dioxide Ferric Oxide Yellow

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-03-20
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, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesiu stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silcon dioxide, stearic acid, talc, titanium dioxide, yellow iron oxide 

Section 51945-4

Peak Life Somnapure 

Clinical Strength 

Nighttime Sleep Aid / Diphenhydramine HCl 

#1 Doctor-Recommended Ingredient

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

30 Sleep Caplets 

One Caplet per Dose

LNK Carton

Section 53413-1

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

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 

  • each caplet contains : calcium 50 mg
  • 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, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesiu stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silcon dioxide, stearic acid, talc, titanium dioxide, yellow iron oxide 

Section 51945-4 (51945-4)

Peak Life Somnapure 

Clinical Strength 

Nighttime Sleep Aid / Diphenhydramine HCl 

#1 Doctor-Recommended Ingredient

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

30 Sleep Caplets 

One Caplet per Dose

LNK Carton

Section 53413-1 (53413-1)

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

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 

  • each caplet contains : calcium 50 mg
  • 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

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Source: dailymed · Ingested: 2026-02-15T11:56:32.932137 · Updated: 2026-03-14T22:55:05.352338