Somnapure Clinical Strength 

Somnapure Clinical Strength 
SPL v4
SPL
SPL Set ID 063517c0-bcb1-46dd-85f1-bbb2f24274ef
Route
ORAL
Published
Effective Date 2020-03-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg)
Inactive Ingredients
Croscarmellose Sodium Dibasic Calcium Phosphate Dihydrate Fd&c Blue No. 1 Aluminum Lake Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Silicon Dioxide Stearic Acid Talc Titanium Dioxide Ferric Oxide Yellow

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-03-20
Description

Active ingredient (in each caplet) Diphenhydramine HCl 50 mg

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Use 

helps to reduce difficulty in falling asleep

Dosage and Administration

Directions

  • adults and children 12 years and over: take 1 caplet at bedtime if needed or as directed by a doctor
  • Children under 12 years: do not use.
Description

Active ingredient (in each caplet) Diphenhydramine HCl 50 mg

Section 50565-1

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. 

Section 50566-9

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

Section 50567-7

When using this product, avoid alcoholic beverages. 

Section 50568-5

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

Section 50569-3

Ask a doctor before use if you have 

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
Section 50570-1

Do not use

  • in children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Section 51727-6

Inactive ingredients   croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silcon dioxide, stearic acid, talc, titanium dioxide, yellow iron oxide 

Section 53413-1

Questions of comments?   Call 1-855-606-6507

Section 53414-9

If pregnant or breastfeeding, ask a health professional before use. 

Section 55105-1

Purpose

Nighttime sleep aid

Section 60561-8

Other information 

  • each caplet contains : calcium 50 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number.
  • protect from moisture
drug Facts

Active ingredient (in each caplet)

Diphenhydramine HCl 50 mg

Principal Display Panel

Force Factor Somnapure

Clinical Strength

Nighttime Sleep Aid / Diphenhydramine HCl

#1 Doctor-Recommended Ingredient

Fall Asleep Quickly

Wake Up Energized

Non-Habit-Forming

30 Caplets

One Caplet per Dose

Structured Label Content

Indications and Usage (34067-9)

Use 

helps to reduce difficulty in falling asleep

Dosage and Administration (34068-7)

Directions

  • adults and children 12 years and over: take 1 caplet at bedtime if needed or as directed by a doctor
  • Children under 12 years: do not use.
Warnings and Precautions (34071-1)

Warnings

Section 50565-1 (50565-1)

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. 

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product, avoid alcoholic beverages. 

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

Section 50569-3 (50569-3)

Ask a doctor before use if you have 

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
Section 50570-1 (50570-1)

Do not use

  • in children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Section 51727-6 (51727-6)

Inactive ingredients   croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silcon dioxide, stearic acid, talc, titanium dioxide, yellow iron oxide 

Section 53413-1 (53413-1)

Questions of comments?   Call 1-855-606-6507

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use. 

Section 55105-1 (55105-1)

Purpose

Nighttime sleep aid

Section 60561-8 (60561-8)

Other information 

  • each caplet contains : calcium 50 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number.
  • protect from moisture
drug Facts (Drug Facts)

Active ingredient (in each caplet)

Diphenhydramine HCl 50 mg

Principal Display Panel (Principal display panel)

Force Factor Somnapure

Clinical Strength

Nighttime Sleep Aid / Diphenhydramine HCl

#1 Doctor-Recommended Ingredient

Fall Asleep Quickly

Wake Up Energized

Non-Habit-Forming

30 Caplets

One Caplet per Dose

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:40.201465 · Updated: 2026-03-14T23:05:34.774689