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. 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 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

QUESTIONS

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

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 / 1-877-869-3304

Boston, MA 02108

INGREDIENTS AND APPEARANCE

SOMNAPURE  CLINICAL STRENGTH
diphenhydramine hydrochloride tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69721-001
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)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
medium-chain triglycerides (UNII: C9H2L21V7U)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	blue	Score	2 pieces
Shape	OVAL	Size	15mm
Flavor		Imprint Code	SPCS
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69721-001-30	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	04/09/2015

Labeler - NutraClick, LLC (831011809)