431 - Sleep Aid Diphenhydramine Hcl 25mg

SPL v4

SPL

SPL Set ID 9746911a-36bc-45eb-adfd-e96439d7a865

Route

ORAL

Published

Effective Date 2021-08-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Imprint: PC11 Shape: capsule Color: purple Size: 15 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-09-21

Description

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Medication Information

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 25 mg

Use(s)

for the relief of occasional sleeplessness
reduces time to fall asleep if you have difficulty falling asleep

Storage

store at 15-30° C (59-86° F)
avoid excessive heat above 40° C (104° F) and high humidity
Protect from light

Questions

Call 1-888-952-0050 Monday through Friday 9AM - 5PM EST

Directions

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

Adults and children 12 years and over: ONE dose = TWO 25 mg softgels (50 mg) at bed time if needed or as directed by a doctor

Do Not Use

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

Other Information

Do not use if blister unit is torn or open.

Do not use if imprinted safety seal under cap is broken or missing.

Active Ingredient(s)

Diphenhydramine HCl 25 mg

Inactive Ingredients

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

Principal Display Panel

Sleep Aid

When Using This Product

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

Ask A Doctor Before Use If

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

Stop Use and Ask A Doctor If

if sleeplessness persists continuously for more than 2 weeks.

Insomnia may be a symptom of serious underlying medical illness.

If Pregnant Or Breastfeeding,

ask a health professional before use.

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 (1-800-222-1222) right away.

Ask A Doctor Or Pharmacist Before Use If

you are taking sedatives or tranquilizers or any other sleep aid

Structured Label Content

Use(s)

for the relief of occasional sleeplessness
reduces time to fall asleep if you have difficulty falling asleep

Purpose

Nighttime sleep-aid

Storage

store at 15-30° C (59-86° F)
avoid excessive heat above 40° C (104° F) and high humidity
Protect from light

Questions

Call 1-888-952-0050 Monday through Friday 9AM - 5PM EST

Directions

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

Adults and children 12 years and over: ONE dose = TWO 25 mg softgels (50 mg) at bed time if needed or as directed by a doctor

Do Not Use (Do not use)

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

Other Information (Other information)

Do not use if blister unit is torn or open.

Do not use if imprinted safety seal under cap is broken or missing.

Active Ingredient(s) (Active ingredient(s))

Diphenhydramine HCl 25 mg

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel

Sleep Aid

When Using This Product (When using this product)

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

Ask A Doctor Before Use If (Ask a doctor before use if)

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

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

if sleeplessness persists continuously for more than 2 weeks.

Insomnia may be a symptom of serious underlying medical illness.

If Pregnant Or Breastfeeding, (If Pregnant or Breastfeeding,)

ask a health professional before use.

Keep Out of Reach of Children (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 (1-800-222-1222) right away.

Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)

you are taking sedatives or tranquilizers or any other sleep aid

Advanced Ingredient Data

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

Raw Label Data

All Sections (JSON)

{"Use(s)": "for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep", "Purpose": "Nighttime sleep-aid", "Storage": "store at 15-30° C (59-86° F) avoid excessive heat above 40° C (104° F) and high humidity Protect from light ", "Questions": "Call 1-888-952-0050 Monday through Friday 9AM - 5PM EST", "Directions": "take only one dose per day (24 hours) - see Overdose warning Adults and children 12 years and over: ONE dose = TWO 25 mg softgels (50 mg) at bed time if needed or as directed by a doctor", "Do not use": "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", "Other information": "Do not use if blister unit is torn or open. Do not use if imprinted safety seal under cap is broken or missing.", "Active ingredient(s)": "Diphenhydramine HCl 25 mg", "Inactive ingredients": "FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special, white edible ink", "Principal Display Panel": "Sleep Aid", "When using this product": "avoid alcoholic beverages and other drugs that cause drowsiness drowsiness will occur be careful when driving a motor vehicle or operating machinery", "Ask a doctor before use if": "a breathing problem such as asthma, emphysema or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland heart disease", "Stop use and ask a doctor if": "if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.", "If Pregnant or Breastfeeding,": "ask a health professional before use.", "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 (1-800-222-1222) right away.", "Ask a doctor or pharmacist before use if": "you are taking sedatives or tranquilizers or any other sleep aid"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:07.509308 · Updated: 2026-03-14T23:08:44.584027