Sominex Max

Sominex Max
SPL v4
SPL
SPL Set ID e8f6991f-c47a-4d12-934b-04fdf092dac3
Route
ORAL
Published
Effective Date 2025-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg)
Inactive Ingredients
Croscarmellose Sodium Calcium Phosphate, Dibasic, Dihydrate Fd&c Blue No. 1 Hypromellose, Unspecified Lactose, Unspecified Form Magnesium Stearate Cellulose, Microcrystalline Mineral Oil Silicon Dioxide Stearic Acid Talc Titanium Dioxide Triacetin

Identifiers & Packaging

Pill Appearance
Imprint: S Shape: capsule Color: blue Size: 15 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2012-06-01 Until 2019-02-01

Description

Drug Facts

Purpose

Nighttime sleep-aid


Medication Information

Purpose

Nighttime sleep-aid

Description

Drug Facts

Use

Helps to reduce difficultly falling asleep

Active

(in each cap let)

Diphenhydramine HCl 50 mg

Section 42229-5

Drug Facts

Section 51945-4

MAXIMUM STRENGTH FORMULA

Sominex®

NIGHTTIME SLEEP-AID DIPHENHYDRAMINE HCl

16 TABLETS

Directions
  • adults and children 12 years and older : take 1 caplet 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  

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

  • keep carton for future reference
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

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

Use

Helps to reduce difficultly falling asleep

Active

(in each cap let)

Diphenhydramine HCl 50 mg

Section 42229-5 (42229-5)

Drug Facts

Section 51945-4 (51945-4)

MAXIMUM STRENGTH FORMULA

Sominex®

NIGHTTIME SLEEP-AID DIPHENHYDRAMINE HCl

16 TABLETS

Purpose

Nighttime sleep-aid

Directions
  • adults and children 12 years and older : take 1 caplet 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  

Other Information (Other information)
  • store at room temperature 20º- 25ºC (68º-77ºF)

  • keep carton for future reference
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

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)