Sominex

Sominex
SPL v2
SPL
SPL Set ID f70ce1a6-c334-025e-e053-6294a90ae53f
Route
ORAL
Published
Effective Date 2020-05-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Calcium Phosphate, Dibasic, Dihydrate Cellulose, Microcrystalline Croscarmellose Sodium Fd&c Blue No. 1 Hypromellose, Unspecified Lactose Monohydrate Light Mineral Oil Magnesium Stearate Silicon Dioxide Stearic Acid Talc Titanium Dioxide Triacetin

Identifiers & Packaging

Pill Appearance
Imprint: S;S Shape: round Color: blue Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-06-01

Description

Drug Facts

Purpose

Nighttime sleep-aid


Medication Information

Purpose

Nighttime sleep-aid

Description

Drug Facts

Use

helps reduce difficultly falling asleep

Section 42229-5

Drug Facts

Directions

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

Do Not Use
  • in children under 12 years of age

  • with any other product containing diphenhydramine, even one used on skin

  • with other antihistamines
Questions?

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

Active Ingredient

(in each tablet)

Diphenhydramine HCl 25 mg

Other Information
  • each tablet contains: calcium 12 mg

  • store at 20º- 25ºC (68º-77ºF)
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

Principal Display Panel

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.

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


Structured Label Content

Use

helps reduce difficultly falling asleep

Section 42229-5 (42229-5)

Drug Facts

Purpose

Nighttime sleep-aid

Directions

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

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
Questions?

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

Active Ingredient

(in each tablet)

Diphenhydramine HCl 25 mg

Other Information (Other information)
  • each tablet contains: calcium 12 mg

  • store at 20º- 25ºC (68º-77ºF)
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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

When Using This Product (When using this product)
  • avoid alcoholic beverages

  • be careful when driving a motor vehicle or operating machinery
Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

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.

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)