Help I Cant Sleep
FDA Label NDC 49260-613

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Help Remedies, Inc. for the product Help I Cant Sleep (NDC 49260-613). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - keep out of reach of children, otc - pregnancy or breast feeding, dosage & administration, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

- 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

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

Sleeplabel (Sleeplabel)

Sleeplabel (Sleeplabel)

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