drug facts

drug facts

SPL v2

SPL

SPL Set ID 27f90f09-7cd5-4d54-b1bf-4e47ca632ac4

Route

oral

Published

Effective Date 2016-02-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

diphenhydramine (25 mg)

Inactive Ingredients

silicon dioxide croscarmellose sodium anhydrous dibasic calcium phosphate magnesium stearate cellulose, microcrystalline titanium dioxide polyvinyl alcohol polyethylene glycol 400 talc fd&c blue no. 1 fd&c blue no. 2

Identifiers & Packaging

Pill Appearance

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

Marketing Status

otc monograph final active Since 2016-02-04

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 25 mg

Medication Information

Warnings

Active Ingredient

Diphenhydramine HCl 25 mg

Uses

provides relief of occasional sleeplessness

Purpose

Nighttime sleep-aid

Directions

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

Other Information

each caplet contains; calcium 25 mg
store at controlled room temperature 15°-30°C (59°-86°F)
avoid excessive heat and humidity

Inactive Ingredients

Colloidal silicon dioxide, Croscarmellose sodium, Dicalcium phosphate, FD&C Blue #1, FD&C Blue #2, Magnesium stearate, Microcrystalline cellulose, Polyethylene glycol, Polyvinyl alcohol, Talc, Titanium dioxide

Description

Diphenhydramine HCl 25 mg

Principal Display Panel

Do Not Use

with any other products containing diphenhydramine, even one used on skin
in children under 12 years of age

Questions Or Comments?

Call: 1-800-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

When Using This Product

drowsiness may occur
avoid alcoholic drinks
do not drive a motor vehicle or operating a 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.

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

Ask A Doctor Before Use If You Have

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

Structured Label Content

Warnings

Active Ingredient (Active ingredient (in each tablet))

Diphenhydramine HCl 25 mg

Uses

provides relief of occasional sleeplessness

Purpose

Nighttime sleep-aid

Directions

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

Other Information

each caplet contains; calcium 25 mg
store at controlled room temperature 15°-30°C (59°-86°F)
avoid excessive heat and humidity

Inactive Ingredients

Principal Display Panel

Do Not Use (Do not use)

with any other products containing diphenhydramine, even one used on skin
in children under 12 years of age

Questions Or Comments? (Questions or comments?)

Call: 1-800-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

When Using This Product (When using this product)

drowsiness may occur
avoid alcoholic drinks
do not drive a motor vehicle or operating a 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.)

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

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
trouble urinating due to an enlarged prostate gland
glaucoma

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

[{"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS DIBASIC CALCIUM PHOSPHATE", "unii": "L11K75P92J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYVINYL ALCOHOL", "unii": "532B59J990", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 2", "unii": "L06K8R7DQK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "provides relief of occasional sleeplessness", "Purpose": "Nighttime sleep-aid", "Directions": "do not take more than directed adults and children 12 years of age and over - take 2 tablets at bedtime if needed or as directed by a doctor children under 12 years of age: do not use", "Do not use": "with any other products containing diphenhydramine, even one used on skin in children under 12 years of age", "Other Information": "each caplet contains; calcium 25 mg store at controlled room temperature 15°-30°C (59°-86°F) avoid excessive heat and humidity", "Inactive Ingredients": "Colloidal silicon dioxide, Croscarmellose sodium, Dicalcium phosphate, FD&C Blue #1, FD&C Blue #2, Magnesium stearate, Microcrystalline cellulose, Polyethylene glycol, Polyvinyl alcohol, Talc, Titanium dioxide", "Questions or comments?": "Call: 1-800-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com", "When using this product": "drowsiness may occur avoid alcoholic drinks do not drive a motor vehicle or operating a 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.": "In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)", "Active ingredient (in each tablet)": "Diphenhydramine HCl 25 mg", "Ask a doctor before use if you have": "a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma", "Ask a doctor or pharmacist before use if you are": "taking sedatives or tranquilizers"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:04.422386 · Updated: 2026-03-14T22:54:16.821321