SOMNAPURE CLINICAL STRENGTH- diphenhydramine hydrochloride tablet, coated 
NutraClick, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Somnapure Clinical Strength 

Drug Facts

Active ingredient (in each caplet)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep aid

Use for relief of occasional sleeplessness

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. 

Directions

Other information 

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 of comments?  Call 1-855-606-6507

Peak Life Somnapure 

Clinical Strength 

Nighttime Sleep Aid / Diphenhydramine HCl 

#1 Doctor-Recommended Ingredient

30 Sleep Caplets 

One Caplet per Dose

LNK Carton

LNK Carton

SOMNAPURE  CLINICAL STRENGTH
diphenhydramine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69721-003
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorblueScoreno score
ShapeOVALSize15mm
FlavorImprint Code 44687
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69721-003-301 in 1 BOX03/20/2018
130 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33803/20/2018
Labeler - NutraClick, LLC (831011809)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464manufacture(69721-003)

Revised: 3/2018
Document Id: 8d952168-b9dd-485e-9776-b4bb068bc02e
Set id: 13e2660d-d0a2-4d57-b2de-4c41257ccf83
Version: 1
Effective Time: 20180320
 
NutraClick, LLC