SOMNAPURE CLINICAL STRENGTH- diphenhydramine hydrochloride tablet, coated

Somnapure by

Drug Labeling and Warnings

Somnapure by is a Otc medication manufactured, distributed, or labeled by NutraClick, LLC, Time-Cap Labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each caplet)

Diphenhydramine HCl 50 mg

PURPOSE

Purpose

Nighttime sleep aid

INDICATIONS & USAGE

Use for relief of occasional sleeplessness

WARNINGS

Warnings

Do not use

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

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

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

When using this product, avoid alcoholic drinks. 

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. 

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

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  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

QUESTIONS

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

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 / 1-855-606-6507

Boston, MA 02108

INGREDIENTS AND APPEARANCE

SOMNAPURE  CLINICAL STRENGTH
diphenhydramine hydrochloride tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69721-002
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg

Inactive Ingredients
Ingredient Name	Strength
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	blue	Score	2 pieces
Shape	OVAL	Size	14mm
Flavor		Imprint Code	SPCS
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69721-002-30	1 in 1 BOX
1		30 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part338	05/26/2015

Labeler - NutraClick, LLC (831011809)

Establishment
Name	Address	ID/FEI	Business Operations
Time-Cap Labs, Inc.		037052099	manufacture(69721-002)