HELP I CANT SLEEP- diphenhydramine tablet

Help I cant Sleep by

Drug Labeling and Warnings

Help I cant Sleep by is a Otc medication manufactured, distributed, or labeled by Help Remedies, Inc. . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

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

PURPOSE

Use: For relief of occasional sleeplessness

WARNINGS

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

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

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)

PREGNANCY OR BREAST FEEDING

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

DOSAGE & ADMINISTRATION

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

INDICATIONS & USAGE

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 INGREDIENT

Inactive Ingredients

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

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HELP I CANT SLEEP 
diphenhydramine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49260-613
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	white (white)	Score	no score
Shape	OVAL (Oval Tablet)	Size	11mm
Flavor		Imprint Code	h;help
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49260-613-50	50 in 1 BOTTLE
2	NDC: 49260-613-16	16 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part336	07/01/2009

Labeler - Help Remedies, Inc. (050359682)

Registrant - Help Remedies, Inc. (050359682)