unisom sleepminis nighttime sleep-aid

SPL v8

SPL

SPL Set ID a9a44c2f-65eb-4a5a-9e72-43652dce57f7

Route

oral

Published

Effective Date 2026-01-14

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

diphenhydramine (25 mg)

Inactive Ingredients

fd&c blue no. 1 anhydrous citric acid gelatin lactose monohydrate polysorbate 80 potassium sorbate starch, corn fd&c red no. 3 titanium dioxide

Identifiers & Packaging

Pill Appearance

Imprint: SleepMinis Shape: oval Color: blue Size: 14 mm Score: 1

Marketing Status

otc monograph drug completed Since 2015-04-01 Until 2020-07-31

Purpose

Nighttime sleep-aid

Description

Drug Facts

Medication Information

Purpose

Nighttime sleep-aid

Directions

adults and children 12 years of age and over: 2 mini-capsules (50 mg) at bedtime if needed, or as directed by a doctor

Inactive Ingredients

blue 1, citric acid, gelatin, lactose, polysorbate 80, potassium sorbate, pregelatinized corn starch, red 3, titanium dioxide (309-121)

Description

Drug Facts

Principal Display Panel

Unisom

#1 Pharmacist Recommended Ingredient*

SleepMinis

Diphenhydramine HCI

Mini-Capsules, 25 mg

NIGHTTIME SLEEP-AID

60 Mini-Capsules

Use

for relief of occasional sleeplessness

Section 42229-5

Drug Facts

Do Not Use

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

Active Ingredient

(in each mini- capsule )

Diphenhydramine HCI 25 mg

When Using This Product

avoid alcoholic drinks

Stop Use and Ask A Doctor If

sleeplessness persist 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.

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

Structured Label Content

Purpose

Nighttime sleep-aid

Directions

adults and children 12 years of age and over: 2 mini-capsules (50 mg) at bedtime if needed, or as directed by a doctor

Inactive Ingredients (Inactive ingredients)

blue 1, citric acid, gelatin, lactose, polysorbate 80, potassium sorbate, pregelatinized corn starch, red 3, titanium dioxide (309-121)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Unisom

#1 Pharmacist Recommended Ingredient*

SleepMinis

Diphenhydramine HCI

Mini-Capsules, 25 mg

NIGHTTIME SLEEP-AID

60 Mini-Capsules

Use

for relief of occasional sleeplessness

Section 42229-5 (42229-5)

Drug Facts

Do Not Use (Do not use)

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

Active Ingredient (Active ingredient)

(in each mini- capsule )

Diphenhydramine HCI 25 mg

When Using This Product (When using this product)

avoid alcoholic drinks

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

sleeplessness persist 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.)

In case of overdose, get medical help or contact a Poison Control Center right away.

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 prostate 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

[{"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": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM SORBATE", "unii": "1VPU26JZZ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 3", "unii": "PN2ZH5LOQY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "for relief of occasional sleeplessness", "42229-5": "Drug Facts", "Purpose": "Nighttime sleep-aid", "Directions": "adults and children 12 years of age and over: 2 mini-capsules (50 mg) at bedtime 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", "Active ingredient": "(in each mini- capsule ) Diphenhydramine HCI 25 mg", "Inactive ingredients": "blue 1, citric acid, gelatin, lactose, polysorbate 80, potassium sorbate, pregelatinized corn starch, red 3, titanium dioxide (309-121)", "PRINCIPAL DISPLAY PANEL": "Unisom #1 Pharmacist Recommended Ingredient* SleepMinis Diphenhydramine HCI Mini-Capsules, 25 mg NIGHTTIME SLEEP-AID 60 Mini-Capsules", "When using this product": "avoid alcoholic drinks", "Stop use and ask a doctor if": "sleeplessness persist 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.": "In case of overdose, get medical help or contact a Poison Control Center right away.", "Ask a doctor before use if you have": "a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland", "Ask a doctor or pharmacist before use if you are": "taking sedatives or tranquilizers"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:12.380224 · Updated: 2026-03-14T23:12:21.703136