sominex-original

sominex-original
SPL v3
SPL
SPL Set ID f7858ecf-8498-4465-85d8-3e7814737573
Route
oral
Published
Effective Date 2025-10-23
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
  • adults and children 12 years and older : take 2 tablets at bedtime if needed, or as directed by your doctor
Other Information

store at room temperature 20º- 25ºC (68º-77ºF)

Inactive Ingredients

croscarmellose sodium, dicalcium phosphate, FD&C blue no. 1 lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, mineral oil, silica, stearate acid, talc, titanium dioxide, triacetin

Description

Drug Facts

Questions?

1-866-255-5202  

Use

helps reduce difficultly falling asleep

Active

(in each cap let)

Diphenhydramine HCl  25 mg

Section 42229-5

Drug Facts

Section 51945-4

MAXIMUM STRENGTH FORMULA

Sominex®

NIGHTTIME SLEEP-AID DIPHENHYDRAMINE HCl

16 TABLETS

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 This Product
  • avoid alcoholic beverages
  • be careful when driving a motor vehicle or operating machinery

  • drowsiness will occur
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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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
  • adults and children 12 years and older : take 2 tablets at bedtime if needed, or as directed by your doctor
Other Information (Other information)

store at room temperature 20º- 25ºC (68º-77ºF)

Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, dicalcium phosphate, FD&C blue no. 1 lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, mineral oil, silica, stearate acid, talc, titanium dioxide, triacetin

Questions?

1-866-255-5202  

Use

helps reduce difficultly falling asleep

Active

(in each cap let)

Diphenhydramine HCl  25 mg

Section 42229-5 (42229-5)

Drug Facts

Section 51945-4 (51945-4)

MAXIMUM STRENGTH FORMULA

Sominex®

NIGHTTIME SLEEP-AID DIPHENHYDRAMINE HCl

16 TABLETS

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 This Product (When using this product)
  • avoid alcoholic beverages
  • be careful when driving a motor vehicle or operating machinery

  • drowsiness will occur
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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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)