SPL v1
SPL
SPL Set ID d52c0cc9-758f-4f38-98db-eee64023d25c
Route
ORAL
Published
Effective Date 2013-05-30
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg)
Inactive Ingredients
Fd&c Blue No. 1 Gelatin Water Sorbitan Sorbitol Polyethylene Glycol 400 Povidone K30

Identifiers & Packaging

Pill Appearance
Imprint: 22 Shape: capsule Color: blue Size: 13 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-05-31
Description

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep- aid

Medication Information

Purpose

Nighttime sleep- aid

Description

Diphenhydramine HCl 50 mg

Use(s)
  • helps to reduce difficulty falling asleep
Storage
  • Store at controlled room temperature 15°-30°C (59°-86°F)
  • do not use if imprinted safety seal under cap is broken or missing
  • *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Maximum Strength Unisom SleepGels®
Warnings

Do not give to children under 12 years of age.

Directions
  • adults and children 12 years of age and over: take 1 softgel at bedtime if needed or as directed by a doctor
Do Not Use
  • With other products containing diphenhydramine, even one used on skin.
Active Ingredient(s)

Diphenhydramine HCl 50 mg

Inactive Ingredients

Gelatin, Sorbitol, Sorbitan, FD&C Blue No. 1, Water, Polyethylene Glycol 400, Povidone K-30

Pregnancy/breastfeeding

Ask a health professional before use.

Principal Display Panel

Carton Label PDP



NDC # 68016-302-32



Sleep-Aid

DIPHENHYDRAMINE HCL 50 mg



GET TO SLEEP FAST

SLEEP SOUNDLY

WAKE REFRESHED



32 Softgels

















Bottle Label PDP



NDC # 68016-302-32



Sleep-Aid

DIPHENHYDRAMINE HCL 50 mg



GET TO SLEEP FAST

SLEEP SOUNDLY

WAKE REFRESHED



32 Softgels









When Using This Product

Avoid alcoholic beverages

Ask A Doctor Before Use If
  • emphysema
  • chronic bronchitis
  • glaucoma
  • difficulty in urination due to an enlargement of the prostate gland
Stop Use and Ask Doctor If
  •  Sleeplessness persists for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
Keep Out of Reach of Children

In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Ask A Doctor Or Pharmacist Before Use If

Sedatives or tranquilizers

Structured Label Content

Use(s) (USE(S))
  • helps to reduce difficulty falling asleep
Purpose (PURPOSE)

Nighttime sleep- aid

Storage (STORAGE)
  • Store at controlled room temperature 15°-30°C (59°-86°F)
  • do not use if imprinted safety seal under cap is broken or missing
  • *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Maximum Strength Unisom SleepGels®
Warnings (WARNINGS)

Do not give to children under 12 years of age.

Directions (DIRECTIONS)
  • adults and children 12 years of age and over: take 1 softgel at bedtime if needed or as directed by a doctor
Do Not Use (DO NOT USE)
  • With other products containing diphenhydramine, even one used on skin.
Active Ingredient(s) (ACTIVE INGREDIENT(S))

Diphenhydramine HCl 50 mg

Inactive Ingredients (INACTIVE INGREDIENTS)

Gelatin, Sorbitol, Sorbitan, FD&C Blue No. 1, Water, Polyethylene Glycol 400, Povidone K-30

Pregnancy/breastfeeding (PREGNANCY/BREASTFEEDING)

Ask a health professional before use.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Carton Label PDP



NDC # 68016-302-32



Sleep-Aid

DIPHENHYDRAMINE HCL 50 mg



GET TO SLEEP FAST

SLEEP SOUNDLY

WAKE REFRESHED



32 Softgels

















Bottle Label PDP



NDC # 68016-302-32



Sleep-Aid

DIPHENHYDRAMINE HCL 50 mg



GET TO SLEEP FAST

SLEEP SOUNDLY

WAKE REFRESHED



32 Softgels









When Using This Product (WHEN USING THIS PRODUCT)

Avoid alcoholic beverages

Ask A Doctor Before Use If (ASK A DOCTOR BEFORE USE IF)
  • emphysema
  • chronic bronchitis
  • glaucoma
  • difficulty in urination due to an enlargement of the prostate gland
Stop Use and Ask Doctor If (STOP USE AND ASK DOCTOR IF)
  •  Sleeplessness persists for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
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 (1-800-222-1222).

Ask A Doctor Or Pharmacist Before Use If (ASK A DOCTOR OR PHARMACIST BEFORE USE IF)

Sedatives or tranquilizers

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:38.367266 · Updated: 2026-03-14T22:53:29.712463