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, LNK International, 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 

• each caplet contains: calcium 50 mg
• store at 15°-30°C (59°-86°F)

INACTIVE INGREDIENT

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 

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

SOMNAPURE  CLINICAL STRENGTH
diphenhydramine hydrochloride tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69721-003
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code	44687
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69721-003-30	1 in 1 BOX	03/20/2018
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	03/20/2018

Labeler - NutraClick, LLC (831011809)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	manufacture(69721-003)