Diphenhydramine Hcl 25mg

SPL v2

SPL

SPL Set ID 12dd2419-b2e0-5466-e063-6394a90a4221

Route

ORAL

Published

Effective Date 2023-10-18

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

Polyethylene Glycol, Unspecified Fd&c Red No. 40 Glycerin Water Gelatin Sorbitol Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance

Imprint: PC11 Shape: capsule Color: purple Size: 15 mm

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-10-18

Description

Diphenhydramine HCl 25 mg

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

for the relief of occasional sleeplessness

reduces time to fall asleep if you have difficulty falling asleep

Dosage and Administration

Diphenhydramine HCl 25 mg

Description

Diphenhydramine HCl 25 mg

Section 43678-2

take only one dose per day (24 hours) - see Overdose warning

adults & Children 12 yrs & over

One dose = TWO 25mg softgels (50mg)

at bedtime if needed or as directed by a doctor

Section 50565-1

Keep out of reach of children. Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center 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 serious underlying medical illness.

Section 50567-7

avoid alcoholic beverages and other drugs that cause drowsiness
drowsiness will occur
be careful when driving a motor vehicle or operating machinery

Section 50568-5

a breathing problem such as asthma, emphysema, or chronic bronchitis
glaucoma
difficulty in urination due to enlargement of the prostate gland
heart disease

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep aid

Section 50570-1

for children under 12 years of age
with any other product containing diphenhydramine, even one used on skin
with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
do not use with NyQuil

Section 51727-6

FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special and white edible ink

Section 51945-4

Section 53414-9

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

Section 55105-1

Nighttime sleep-aid

Section 55106-9

Diphenhydramine HCl 25 mg

Structured Label Content

Indications and Usage (34067-9)

for the relief of occasional sleeplessness

reduces time to fall asleep if you have difficulty falling asleep

Dosage and Administration (34068-7)

Diphenhydramine HCl 25 mg

Warnings and Precautions (34071-1)

Warnings

Section 43678-2 (43678-2)

take only one dose per day (24 hours) - see Overdose warning

adults & Children 12 yrs & over

One dose = TWO 25mg softgels (50mg)

at bedtime if needed or as directed by a doctor

Section 50565-1 (50565-1)

Keep out of reach of children. Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center 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 serious underlying medical illness.

Section 50567-7 (50567-7)

avoid alcoholic beverages and other drugs that cause drowsiness
drowsiness will occur
be careful when driving a motor vehicle or operating machinery

Section 50568-5 (50568-5)

a breathing problem such as asthma, emphysema, or chronic bronchitis
glaucoma
difficulty in urination due to enlargement of the prostate gland
heart disease

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep aid

Section 50570-1 (50570-1)

for children under 12 years of age
with any other product containing diphenhydramine, even one used on skin
with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
do not use with NyQuil

Section 51727-6 (51727-6)

FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special and white edible ink

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Nighttime sleep-aid

Section 55106-9 (55106-9)

Diphenhydramine HCl 25 mg

Advanced Ingredient Data

[{"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep", "34068-7": "Diphenhydramine HCl 25 mg", "34071-1": "Warnings", "43678-2": "take only one dose per day (24 hours) - see Overdose warning adults & Children 12 yrs & over One dose = TWO 25mg softgels (50mg) at bedtime if needed or as directed by a doctor", "50565-1": "Keep out of reach of children. Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.", "50566-9": "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.", "50567-7": "avoid alcoholic beverages and other drugs that cause drowsiness drowsiness will occur be careful when driving a motor vehicle or operating machinery", "50568-5": "a breathing problem such as asthma, emphysema, or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland heart disease Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep aid", "50570-1": "for children under 12 years of age with any other product containing diphenhydramine, even one used on skin with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products do not use with NyQuil", "51727-6": "FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special and white edible ink", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Nighttime sleep-aid", "55106-9": "Diphenhydramine HCl 25 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:08.118201 · Updated: 2026-03-14T23:12:17.704012