Sominex

Sominex DIPHENHYDRAMINE HYDROCHLORIDE NAVAJO MANUFACTURING COMPANY INC. FDA Approved Use helps reduce difficultly falling asleep

Generic: DIPHENHYDRAMINE HYDROCHLORIDE

Mfr: NAVAJO MANUFACTURING COMPANY INC. FDA OTC

Substance Diphenhydramine Hydrochloride

Route

ORAL

Applications

M010

Product NDC

67751-0221-00 67751-0221-01

Package NDC

67751-221-01

Drug Facts

Composition & Profile

Active Ingredients

Active Ingredient (in each tablet) Diphenhydramine HCl 25 mg

Inactive Ingredients

Inactive ingredients cellulose microcrystalline croscarmellose sodium FD&C blue no. 1 hypromellose lactose monohydrate light mineral oil magnesium stearate silicon dioxide stearic acid talc titanium dioxide triacetin

Strengths

25 mg

Treats Conditions

Use Helps Reduce Difficultly Falling Asleep

Pill Appearance

Shape: round Color: blue Imprint: S;S

Identifiers & Packaging

Container Type UNKNOWN

NDC 67751-0221-00

All Product Codes

67751-0221-00 67751-0221-01

UNII

TC2D6JAD40

SPL Set IDs

f70ce1a6-c334-025e-e053-6294a90ae53f

Packaging

PRINCIPAL DISPLAY PANEL Sominex

Package Descriptions

PRINCIPAL DISPLAY PANEL Sominex

Overview

Use helps reduce difficultly falling asleep

Indications & Usage

Use helps reduce difficultly falling asleep

Dosage & Administration

Directions A dults and children 12 years and older : take 2 tablets at bedtime if needed, or as directed by your doctor

Warnings & Precautions

Warnings Do not use in children under 12 years of age with any other product containing diphenhydramine, even one used on skin with other antihistamines 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 beverages be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose get medical help or contact a Poison Control Center right away.

Purpose

Purpose Nighttime sleep-aid

Do Not Use

Do not use in children under 12 years of age with any other product containing diphenhydramine, even one used on skin with other antihistamines

When Using

When using this product avoid alcoholic beverages be careful when driving a motor vehicle or operating machinery

Stop Use & Ask a Doctor

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

Keep Out of Reach of Children

Keep out of reach of children. In case of accidental overdose get medical help or contact a Poison Control Center right away.

Questions

Questions? 1-866-255-5202 weekdays or visit www.sominex.com