HELP I CANT SLEEP - diphenhydramine tablet 
Help Remedies, Inc.

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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Drug Facts


Active Ingredient...................................................Purpose
(in each caplet)


Diphenhydramine HCl 25 mg...................................Nighttime/sleep aid

Use: For relief of occasional sleeplessness

Warnings

- Ask a doctor before use if you have • a breathing problem such as emphysema or chronic bronchitis • glaucoma • trouble urinating due to an enlarged prostate gland.

- Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers.

- When using this product:
• avoid alcoholic drinks • drowsiness may occur • do not drive a motor vehicle or operate machinery after use.

- Stop and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious
underlying medical illness

Do not use

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

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

If pregnant or breast feeding, ask a health professional before use.


Directions

• do not take more than directed
• adults and children 12 years and over: take 2 caplets at bedtime if needed, or as directed by a doctor
• children under 12 years of age: do not use


Other Information
 
• each caplet contains: calcium 23mg.
• store at room temperature 25°C (77°F) excursions permitted between 15-30°C (59-86°F)
• avoid excessive heat and humidity .
• use by expiration date on package.
• do not use if packet is torn, cut or opened.
• keep carton. They contain important information.


Inactive Ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium
phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose,
polyethelene glycol, polysorbate 80, titanium dioxide.

Distributed by Help Remedies,
57 W. 28th St. Fl. 4
New York, NY 10001
www.helpineedhelp.com

sleeplabel

HELP I CANT SLEEP 
diphenhydramine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49260-613
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
Product Characteristics
Colorwhite (white) Scoreno score
ShapeOVAL (Oval Tablet) Size11mm
FlavorImprint Code h;help
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49260-613-5050 in 1 BOTTLE
2NDC:49260-613-1616 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33607/01/2009
Labeler - Help Remedies, Inc. (050359682)
Registrant - Help Remedies, Inc. (050359682)

Revised: 7/2011
Document Id: 0e723c3c-c6bd-46b2-9302-1faec8278095
Set id: a182d099-1b11-4d88-a246-f2e2ae75f340
Version: 1
Effective Time: 20110711
 
Help Remedies, Inc.