Nighttime Sleep Aid

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

Silicon Dioxide Croscarmellose Sodium Anhydrous Dibasic Calcium Phosphate Fd&c Blue No. 1 Fd&c Blue No. 2 Lecithin, Soybean Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Titanium Dioxide Talc

Identifiers & Packaging

Pill Appearance

Imprint: S5 Shape: capsule Color: blue Size: 11 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-06-29

Medication Information

Purpose

Night Time Sleep Aid

Description

Diphenhydramine HCl 25mg

Uses:

for relief of occasional sleeplessness

Section 50566-9

Stop use and ask a doctor if:

■ sleeplessness persist continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

Section 50567-7

When using this product:

■ avoid alcoholic drinks

■ drowsiness will occur

■ do not drive a motorvehicle or operate machinery.

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

■ trouble urinating due to an enlarged prostate gland.

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Warnings:

Do not use:

■ in children under 12 years of age ■with any other product containing diphenhydramine, even one used on skin.

Directions

■ do not take more than directed(See overdose warning)

■ adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by doctor

■ children under 12 years: do not use

Other Information

■each caplet contains: calcium 23.52 mg

■store between 15-30°C (59-86°F).

■Avoid high humidity.

■ Protect from light.

Inactive Ingredients

Colloidal Silicon, Croscarmellose, Sodium, Dicalcium Phosphate, FD&C Blue#1, FD&C Blue#2, Lethicin, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol , Titanium Dioxide, Talc.

Questions Or Comments?

Call toll free 1-732-698-5070 Mon to Fri 9am – 5pm.

Principal Display Panel

Keep Out of Reach of Children

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

Active Ingredient (in Each Caplet)

Diphenhydramine HCl 25mg

Structured Label Content

Uses:

for relief of occasional sleeplessness

Section 50566-9 (50566-9)

Stop use and ask a doctor if:

■ sleeplessness persist continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

Section 50567-7 (50567-7)

When using this product:

■ avoid alcoholic drinks

■ drowsiness will occur

■ do not drive a motorvehicle or operate machinery.

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

■ trouble urinating due to an enlarged prostate gland.

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Purpose

Night Time Sleep Aid

Warnings:

Do not use:

■ in children under 12 years of age ■with any other product containing diphenhydramine, even one used on skin.

Directions (DIRECTIONS)

■ do not take more than directed(See overdose warning)

■ adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by doctor

■ children under 12 years: do not use

Other Information (OTHER INFORMATION)

■each caplet contains: calcium 23.52 mg

■store between 15-30°C (59-86°F).

■Avoid high humidity.

■ Protect from light.

Inactive Ingredients (INACTIVE INGREDIENTS)

Colloidal Silicon, Croscarmellose, Sodium, Dicalcium Phosphate, FD&C Blue#1, FD&C Blue#2, Lethicin, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol , Titanium Dioxide, Talc.

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Call toll free 1-732-698-5070 Mon to Fri 9am – 5pm.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

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

Active Ingredient (in Each Caplet) (Active Ingredient (in each caplet))

Diphenhydramine HCl 25mg

Advanced Ingredient Data

[{"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS DIBASIC CALCIUM PHOSPHATE", "unii": "L11K75P92J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 2", "unii": "L06K8R7DQK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LECITHIN, SOYBEAN", "unii": "1DI56QDM62", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses:": "for relief of occasional sleeplessness", "50566-9": "Stop use and ask a doctor if: ■ sleeplessness persist continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.", "50567-7": "When using this product: ■ avoid alcoholic drinks ■ drowsiness will occur ■ do not drive a motorvehicle or operate machinery.", "50568-5": "Ask a doctor or pharmacist before use if you are: ■taking sedatives or tranquilizers.", "50569-3": "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.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Night Time Sleep Aid", "Warnings:": "Do not use: ■ in children under 12 years of age ■with any other product containing diphenhydramine, even one used on skin.", "DIRECTIONS": "■ do not take more than directed (See overdose warning) ■ adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by doctor ■ children under 12 years: do not use", "OTHER INFORMATION": "■each caplet contains: calcium 23.52 mg ■store between 15-30°C (59-86°F). ■Avoid high humidity. ■ Protect from light.", "INACTIVE INGREDIENTS": "Colloidal Silicon, Croscarmellose, Sodium, Dicalcium Phosphate, FD&C Blue#1, FD&C Blue#2, Lethicin, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol , Titanium Dioxide, Talc.", "QUESTIONS OR COMMENTS?": "Call toll free 1-732-698-5070 M on to Fri 9am – 5pm.", "KEEP OUT OF REACH OF CHILDREN": "Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222).", "Active Ingredient (in each caplet)": "Diphenhydramine HCl 25mg"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information