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

Purpose

Nighttime sleep-aid

Description

Drug Facts


Medication Information

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

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

Description

Drug Facts

Principal Display Panel

Questions?

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

Use

helps reduce difficultly falling asleep

Section 42229-5

Drug Facts

Do Not Use
  • in children under 12 years of age

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

  • with other antihistamines
Active Ingredient

(in each tablet)

Diphenhydramine HCl 25 mg

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

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

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)

Questions?

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

Use

helps reduce difficultly falling asleep

Section 42229-5 (42229-5)

Drug Facts

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
Active Ingredient

(in each tablet)

Diphenhydramine HCl 25 mg

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)