Pill Identifier App

Help I cant Sleep

Dosage form: tablet
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Help Remedies, Inc.
NDC Code: 49260-613

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.

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

HELP I CANT SLEEP 
diphenhydramine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49260-613
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYSORBATE 80 
TITANIUM DIOXIDE 
POLYETHYLENE GLYCOL 
Product Characteristics
Colorwhite (white) Scoreno score
ShapeOVAL (Oval Tablet) Size11mm
FlavorImprint Codeh;help
Contains    
Packaging
#Item CodePackage Description
1NDC:49260-613-5050 TABLET (TABLET) in 1 BOTTLE
2NDC:49260-613-1616 TABLET (TABLET) 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: 07/2011
 
Help Remedies, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web2)