target nighttime sleep-aid diphenhydramine hydrochloride 25 mg tablets

SPL v2

SPL

SPL Set ID fc7ed67f-bac9-f9ed-e053-6294a90ad9a1

Route

oral

Published

Effective Date 2023-12-16

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

diphenhydramine (25 mg)

Inactive Ingredients

silicon dioxide magnesium stearate polyvinyl alcohol, unspecified titanium dioxide carnauba wax fd&c blue no. 1 aluminum lake dibasic calcium phosphate dihydrate polyethylene glycol, unspecified croscarmellose sodium microcrystalline cellulose talc

Identifiers & Packaging

Pill Appearance

Imprint: T129 Shape: capsule Color: blue Size: 11 mm Score: 1

Marketing Status

otc monograph drug active Since 2024-01-15

Purpose

Nighttime sleep aid

Description

Diphenhydramine HCl 25 mg

Medication Information

Warnings and Precautions

Warnings

Uses

■ for relief of occasional sleeplessness

Purpose

Nighttime sleep aid

Directions

Do not take more than directed.

See overdose warning

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

Other Information

■ each caplet contains: calcium 25 mg

■ store between 20-25°C (68-77°F). Avoid high humidity. Protect from light

Inactive Ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Description

Diphenhydramine HCl 25 mg

Section 51945-4

Do Not Use

■ in children under 12 years of age

■ with any other product containing diphenhydramine, even one used on skin

Questions Or Comments?

Call 1-800-910-6874

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 overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Active Ingredient (in Each Caplet)

Diphenhydramine HCl 25 mg

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 Pharmacist Before Use If You Are

taking sedatives or tranquilizers

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Uses

■ for relief of occasional sleeplessness

Purpose

Nighttime sleep aid

Directions

Do not take more than directed.

See overdose warning

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

Other Information (Other information)

■ each caplet contains: calcium 25 mg

■ store between 20-25°C (68-77°F). Avoid high humidity. Protect from light

Inactive Ingredients (Inactive ingredients)

Section 51945-4 (51945-4)

Do Not Use (Do not use)

■ in children under 12 years of age

■ with any other product containing diphenhydramine, even one used on skin

Questions Or Comments? (Questions or comments?)

Call 1-800-910-6874

When Using This Product (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 (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, (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: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have (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 Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "■ for relief of occasional sleeplessness", "34071-1": "Warnings", "Purpose": "Nighttime sleep aid", "Directions": "Do not take more than directed. See overdose warning adults and children 12 years and over take 2 caplets at bedtime if needed, or as directed by a doctor children under 12 years do not use", "Do not use": "■ in children under 12 years of age ■ with any other product containing diphenhydramine, even one used on skin", "Other information": "■ each caplet contains: calcium 25 mg ■ store between 20-25°C (68-77°F). Avoid high humidity. Protect from light", "Inactive ingredients": "carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide", "Questions or comments?": "Call 1-800-910-6874", "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 overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).", "Active ingredient (in each caplet)": "Diphenhydramine HCl 25 mg", "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 pharmacist before use if you are": "taking sedatives or tranquilizers"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:41.589863 · Updated: 2026-03-14T23:02:23.126471