FDA Label for Help I Cant Sleep
View Indications, Usage & Precautions
Help I Cant Sleep Product Label
The following document was submitted to the FDA by the labeler of this product Help Remedies, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredient...................................................Purpose
(in each caplet)
Diphenhydramine HCl 25 mg...................................Nighttime/sleep aid
Otc - 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.
underlying medical illness
Otc - Do Not Use
Do not use
• with any other product containing diphenhydramine, even one used on skin • in children under 12 years of age.
Otc - 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)
Otc - 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 Ingredientscarnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calciumphosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethelene glycol, polysorbate 80, titanium dioxide.
Otc - Questions
Distributed by Help Remedies,
57 W. 28th St. Fl. 4
New York, NY 10001
www.helpineedhelp.com
Package Label.Principal Display Panel
* Please review the disclaimer below.