d52c0cc9-758f-4f38-98db-eee64023d25c

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

Purpose

Nighttime sleep- aid

Description

Diphenhydramine HCl 50 mg

Medication Information

Warnings

Do not give to children under 12 years of age.

Purpose

Nighttime sleep- aid

Directions

adults and children 12 years of age and over: take 1 softgel at bedtime if needed or as directed by a doctor

Inactive Ingredients

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

Description

Diphenhydramine HCl 50 mg

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

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®

Do Not Use

With other products containing diphenhydramine, even one used on skin.

Active Ingredient(s)

Diphenhydramine HCl 50 mg

Pregnancy/breastfeeding

Ask a health professional before use.

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

Warnings (WARNINGS)

Do not give to children under 12 years of age.

Purpose (PURPOSE)

Nighttime sleep- aid

Directions (DIRECTIONS)

adults and children 12 years of age and over: take 1 softgel at bedtime if needed or as directed by a doctor

Inactive Ingredients (INACTIVE INGREDIENTS)

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

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

Use(s) (USE(S))

helps to reduce difficulty falling asleep

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®

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

Pregnancy/breastfeeding (PREGNANCY/BREASTFEEDING)

Ask a health professional before use.

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

[{"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITAN", "unii": "6O92ICV9RU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE K30", "unii": "U725QWY32X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USE(S)": "helps to reduce difficulty falling asleep", "PURPOSE": "Nighttime sleep- aid", "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"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

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