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 

helps to reduce difficulty in falling asleep

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 or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product, avoid alcoholic beverages. 

Stop use and ask a doctor if sleeplessness persists continuously for more than 2 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 (1-800-222-1222)  right away. 

DOSAGE & ADMINISTRATION

Directions

• adults and children 12 years and over: take 1 caplet at bedtime if needed or as directed by a doctor
• Children under 12 years: do not use.

OTHER SAFETY INFORMATION

Other information 

• each caplet contains: calcium 50 mg
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• see end flap for expiration date and lot number.
• protect from moisture

INACTIVE INGREDIENT

Inactive ingredients  croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium 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

Force Factor Somnapure

Clinical Strength

Nighttime Sleep Aid / Diphenhydramine HCl

#1 Doctor-Recommended Ingredient

Fall Asleep Quickly
Wake Up Energized
Non-Habit-Forming

30 Caplets

One Caplet per Dose

INGREDIENTS AND APPEARANCE

SOMNAPURE  CLINICAL STRENGTH
diphenhydramine hydrochloride tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69721-005
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--ALUMINUM LAKE (UNII: J9EQA3S2JM)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (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: 69721-005-30	1 in 1 CARTON	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)