Nighttime Sleep-aid

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

D&c Blue No. 4 Hypromelloses Isopropyl Alcohol Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol 400 Titanium Dioxide Croscarmellose Talc Dibasic Calcium Phosphate Dihydrate

Identifiers & Packaging

Pill Appearance

Imprint: S1 Shape: capsule Color: blue Size: 12 mm Score: 1

Marketing Status

OTC MONOGRAPH FINAL Active Since 2018-12-20

Medication Information

Warnings and Precautions

Do not use

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

Ask a doctor before use if you have

a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostrate gland

Ask a doctor or a pharmacist before use if

you are taking sedatives or tranquilzers

When using this product

avoid alcoholic drinks
drowsiness will occur
do not drive a motor vehicle or operate machinery

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

Overdose warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Indications and Usage

for relief of occasional sleeplessness

Dosage and Administration

take with a full glass of water
do not take more than directed

adults and children 12 years of age and over	2 caplets at bedtime if needed, or as directed by a doctor
children under 12 years of age	do not use

Description

Diphenhydramine HCl 25mg

Section 50565-1

Keep out of reach of children

Overdose Warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 51727-6

croscarmellose sodium, D&C blue #4 aluminium lake, dibasic calcium phosphate, hydroxy propyl methyl cellulose, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, polyethyl;ene glycol, talc, titanium dioxide

Section 51945-4

Section 55105-1

Nighttime sleep-aid

Section 55106-9

Diphenhydramine HCl 25mg

Section 60561-8

store at room temperature between 20 ^ºC - 25 ^ºC (68 ^ºF - 77 ^ºF)
avoid high humidity
protect from light

Structured Label Content

Indications and Usage (34067-9)

for relief of occasional sleeplessness

Dosage and Administration (34068-7)

take with a full glass of water
do not take more than directed

adults and children 12 years of age and over	2 caplets at bedtime if needed, or as directed by a doctor
children under 12 years of age	do not use

Warnings and Precautions (34071-1)

Do not use

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

Ask a doctor before use if you have

a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostrate gland

Ask a doctor or a pharmacist before use if

you are taking sedatives or tranquilzers

When using this product

avoid alcoholic drinks
drowsiness will occur
do not drive a motor vehicle or operate machinery

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

Overdose warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50565-1 (50565-1)

Keep out of reach of children

Overdose Warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 51727-6 (51727-6)

croscarmellose sodium, D&C blue #4 aluminium lake, dibasic calcium phosphate, hydroxy propyl methyl cellulose, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, polyethyl;ene glycol, talc, titanium dioxide

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Nighttime sleep-aid

Section 55106-9 (55106-9)

Diphenhydramine HCl 25mg

Section 60561-8 (60561-8)

store at room temperature between 20 ^ºC - 25 ^ºC (68 ^ºF - 77 ^ºF)
avoid high humidity
protect from light

Advanced Ingredient Data

[{"name": "D&C BLUE NO. 4", "unii": "0KSY80VYS3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "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 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE", "unii": "029TFK992N", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIBASIC CALCIUM PHOSPHATE DIHYDRATE", "unii": "O7TSZ97GEP", "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)

{"34067-9": "for relief of occasional sleeplessness", "34068-7": "take with a full glass of water do not take more than directed adults and children 12 years of age and over 2 caplets at bedtime if needed, or as directed by a doctor children under 12 years of age do not use", "34071-1": "Do not use in children under 12 years of age with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostrate gland Ask a doctor or a pharmacist before use if you are taking sedatives or tranquilzers When using this product avoid alcoholic drinks drowsiness will occur do not drive a motor vehicle or operate machinery 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 Overdose warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "50565-1": "Keep out of reach of children Overdose Warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "51727-6": "croscarmellose sodium, D&C blue #4 aluminium lake, dibasic calcium phosphate, hydroxy propyl methyl cellulose, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, polyethyl;ene glycol, talc, titanium dioxide", "55105-1": "Nighttime sleep-aid", "55106-9": "Diphenhydramine HCl 25mg", "60561-8": "store at room temperature between 20 º C - 25 º C (68 º F - 77 º F) avoid high humidity protect from light"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information