Nighttime Sleep Aid-diphenhydramine Hcl 25 Mg

Nighttime Sleep Aid-diphenhydramine Hcl 25 Mg
SPL v11
SPL
SPL Set ID d659f747-9790-8bd6-e053-2995a90ae793
Route
ORAL
Published
Effective Date 2025-06-18
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 Water Silicon Dioxide Magnesium Stearate Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Fd&c Blue No. 1 Fd&c Blue No. 2 Titanium Dioxide Talc Lecithin, Soybean

Identifiers & Packaging

Pill Appearance
Imprint: S25 Shape: capsule Color: blue Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-18

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, Polyvinyl Alcohol, Talc, Titanium dioxide, Polyethylene Glycol, Lecithin, Brilliant Blue (FD&C Blue No. 1), Indico Carmel (FD&C Blue No. 2), Purified Water.

Questions Or Comments?

Call toll free 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

Principal Display Panel 300 Count

Principal Display Panel 600 Count

Active Ingredient (in Each Caplet)

Diphenhydramine HCl 25 mg

Principal Display Panel 1000 Count

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

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

Colloidal Silicon Dioxide, Croscarmellose Sodium, Dicalcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose, Polyvinyl Alcohol, Talc, Titanium dioxide, Polyethylene Glycol, Lecithin, Brilliant Blue (FD&C Blue No. 1), Indico Carmel (FD&C Blue No. 2), Purified Water.

Questions Or Comments? (Questions or comments?)

Call toll free 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.)

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

Principal Display Panel 300 Count (Principal Display Panel-300 count)

Principal Display Panel 600 Count (Principal Display Panel-600 count)

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

Diphenhydramine HCl 25 mg

Principal Display Panel 1000 Count (Principal Display Panel-1000 count)

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

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


Raw Label Data

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