FDA.reportPublic FDA data

Somnapure

Manufacturer
NutraClick, LLC
Effective date
2020-03-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:39:47

Label at a glance#

ProductSomnapure Clinical Strength
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet)

Diphenhydramine HCl 50 mg

OTC - PURPOSE SECTION

Purpose

Nighttime sleep aid

INDICATIONS & USAGE SECTION

Use for relief of occasional sleeplessness

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

Do not use

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

OTC - ASK DOCTOR SECTION

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 SECTION

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

OTC - WHEN USING SECTION

When using this product, avoid alcoholic drinks. 

OTC - STOP USE SECTION

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 SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 

  • each caplet contains: calcium 35 mg
  • store at 15°-30°C (59°-86°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients  collodial silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, stearic acid

OTC - QUESTIONS SECTION

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

Principal display panel

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

15 Sleep Caplets

One Caplet per Dose

Distributed by Peak Life, LLC,

a subsidiary of NutraClick, LLC

PeakLife.com / 1-855-606-6507

Boston, MA 02108

LabelLabel

BoxBox

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69721-004-302022-02-01C16284748780-1d6a99b39-bbcd-a426-e053-dadaa90af4c2Somnapure Clinical Strength
69721-004-302022-01-28C16284748780-1d6a99b39-bbcd-a426-e053-dadaa90af4c2Somnapure Clinical Strength

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69721-00469721-004-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
FD&C BLUE NO. 1--ALUMINUM LAKEJ9EQA3S2JMIACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
MINERAL OILT5L8T28FGPIACT
STEARIC ACID4ELV7Z65APIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f70b2e99-7826-4ede-a3e0-a64bc9331a64d8706907-3648-4183-a7cc-4b3577b83e8e2022-01-24WarningsExact identifier
spl set id: d8706907-3648-4183-a7cc-4b3577b83e8e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.