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SPL v1

SPL

SPL Set ID 7e8196ec-6695-40b0-a212-e14e9bb606fa

Route

ORAL

Published

Effective Date 2025-09-25

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

Anhydrous Dibasic Calcium Phosphate Microcrystalline Cellulose Croscarmellose Sodium Silicon Dioxide Magnesium Stearate Fd&c Blue No. 1 Fd&c Blue No. 2 Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: S25 Shape: capsule Color: blue Size: 11 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-09-25

Description

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Medication Information

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 25 mg

Uses:

relief of occasional sleeplessness

Warnings

Directions

do not take more than directed(see overdose warning)
adults and children 12 years of age and over:- take 2 caplets at bedtime if needed or as directed by a doctor
children under 12 years of age: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

Each caplet contains: Calcium 23.52 mg
store at controlled room temperature 25°C (77°F); excursions permitted between 15-30°C (59-86°F)
read all product information before using

Inactive Ingredients

Colloidal Silicon Dioxide, Croscarmellose Sodium, Dicalcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose (PH-102), Titanium dioxide, Brilliant Blue FCF Aluminum lack (FD&C Blue No. 1), Indico Carmel lake (FD&C Blue No. 2).

Questions Or Comments?

Call 1-844-832-1138

9AM – 5PM Monday - Friday

When Using This Product

drowsiness will occur
avoid alcoholic beverages and other drugs that cause drowsiness
excitability may occur, especially in children
alcohol, sedatives and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If

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

If Pregnant Or Breast Feeding,

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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms

Active Ingredient (in Each Caplet)

Diphenhydramine HCl 25 mg

Principal Display Panel 300 Caplets

Principal Display Panel 600 Caplets

Ask A Doctor Before Use If You Have

a breathing problem such as asthma, emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland
heart disease

Principal Display Panel 1000 Caplets

Ask Your Doctor Or Pharmacist Before Use If You Are

taking sedative or tranquilizers or any other sleep-aid

Structured Label Content

Uses:

relief of occasional sleeplessness

Purpose

Nighttime sleep-aid

Warnings

Directions

do not take more than directed(see overdose warning)
adults and children 12 years of age and over:- take 2 caplets at bedtime if needed or as directed by a doctor
children under 12 years of age:do not use

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

Each caplet contains: Calcium 23.52 mg
store at controlled room temperature 25°C (77°F); excursions permitted between 15-30°C (59-86°F)
read all product information before using

Inactive Ingredients

Questions Or Comments? (Questions or comments?)

Call 1-844-832-1138

9AM – 5PM Monday - Friday

When Using This Product (When using this product)

drowsiness will occur
avoid alcoholic beverages and other drugs that cause drowsiness
excitability may occur, especially in children
alcohol, sedatives and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery

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

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

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Diphenhydramine HCl 25 mg

Principal Display Panel 300 Caplets (Principal Display Panel-300 Caplets)

Principal Display Panel 600 Caplets (Principal Display Panel-600 Caplets)

Ask A Doctor Before Use If You Have (ask a doctor before use if you have)

a breathing problem such as asthma, emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland
heart disease

Principal Display Panel 1000 Caplets (Principal Display Panel-1000 Caplets)

Ask Your Doctor Or Pharmacist Before Use If You Are (ask your doctor or pharmacist before use if you are)

taking sedative or tranquilizers or any other sleep-aid

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses:": "relief of occasional sleeplessness", "Purpose": "Nighttime sleep-aid", "Directions": "do not take more than directed(see overdose warning) adults and children 12 years of age and over:- take 2 caplets at bedtime if needed or as directed by a doctor children under 12 years of age: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": "Each caplet contains: Calcium 23.52 mg store at controlled room temperature 25°C (77°F); excursions permitted between 15-30°C (59-86°F) read all product information before using", "Inactive Ingredients": "Colloidal Silicon Dioxide, Croscarmellose Sodium, Dicalcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose (PH-102), Titanium dioxide, Brilliant Blue FCF Aluminum lack (FD&C Blue No. 1), Indico Carmel lake (FD&C Blue No. 2).", "Questions or comments?": "Call 1-844-832-1138 9AM – 5PM Monday - Friday", "When using this product": "drowsiness will occur avoid alcoholic beverages and other drugs that cause drowsiness excitability may occur, especially in children alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery", "Stop use and ask a doctor if": "sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness", "If pregnant or breast-feeding,": "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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms", "Active ingredient (in each caplet)": "Diphenhydramine HCl 25 mg", "ask a doctor before use if you have": "a breathing problem such as asthma, emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland heart disease", "ask your doctor or pharmacist before use if you are": "taking sedative or tranquilizers or any other sleep-aid"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:06.647635 · Updated: 2026-03-14T23:10:19.800513