Greenfield - Sleep Aid

SPL v4

SPL

SPL Set ID 2890e4ba-d642-437d-8a86-24996a74e027

Route

ORAL

Published

Effective Date 2021-11-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

Croscarmellose Sodium Fd&c Blue No. 1 Aluminum Lake Hypromellose, Unspecified Lactose, Unspecified Form Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Silicon Dioxide Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 263;arch Shape: oval Color: blue Size: 12 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-11-23

Description

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep aid

Medication Information

Purpose

Nighttime sleep aid

Description

Diphenhydramine HCl 25 mg

Use(s)

for relief of occasional sleeplessness

Directions

adults and children 12 years 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

In children under 12 years of age
With any other product containing diphenydramine, even one used on skin

Other Information

store at room temperature 20°– 25°C (68°– 77°F)
do not use if blister unit is torn or open
you may report side effects to 1-888-952-0050

Active Ingredient(s)

Diphenhydramine HCl 25 mg

Inactive Ingredients

croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, lactose, magnesium

stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

Pregnancy/breastfeeding

If pregnant or breast-feeding, ask a health professional before use.

Principal Display Panel

Sleep Aid

When Using This Product

avoid alcoholic beverages
drowsiness will occur
do not drive a motor vehicle or operate machinery

Ask A Doctor Before Use If

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

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.

Keep Out of Reach of Children

In case of accidental overdose, contact a doctor or Poison Control Center right away.

Ask A Doctor Or Pharmacist Before Use If

you are taking sedatives or tranquilizers

Structured Label Content

Use(s)

for relief of occasional sleeplessness

Purpose

Nighttime sleep aid

Directions

adults and children 12 years 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)

In children under 12 years of age
With any other product containing diphenydramine, even one used on skin

Other Information (Other information)

store at room temperature 20°– 25°C (68°– 77°F)
do not use if blister unit is torn or open
you may report side effects to 1-888-952-0050

Active Ingredient(s) (Active ingredient(s))

Diphenhydramine HCl 25 mg

Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, lactose, magnesium

stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

Pregnancy/breastfeeding (Pregnancy/Breastfeeding)

If pregnant or breast-feeding, ask a health professional before use.

Principal Display Panel

Sleep Aid

When Using This Product (When using this product)

avoid alcoholic beverages
drowsiness will occur
do not drive a motor vehicle or operate machinery

Ask A Doctor Before Use If (Ask a doctor before use if)

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

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.

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

In case of accidental overdose, contact a doctor or Poison Control Center right away.

Ask A Doctor Or Pharmacist Before Use If (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": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1 ALUMINUM LAKE", "unii": "J9EQA3S2JM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE, UNSPECIFIED FORM", "unii": "J2B2A4N98G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use(s)": "for relief of occasional sleeplessness", "Purpose": "Nighttime sleep aid", "Directions": "adults and children 12 years 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": "In children under 12 years of age With any other product containing diphenydramine, even one used on skin", "Other information": "store at room temperature 20°– 25°C (68°– 77°F) do not use if blister unit is torn or open you may report side effects to 1-888-952-0050", "Active ingredient(s)": "Diphenhydramine HCl 25 mg", "Inactive ingredients": "croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide", "Pregnancy/Breastfeeding": "If pregnant or breast-feeding, ask a health professional before use.", "Principal Display Panel": "Sleep Aid", "When using this product": "avoid alcoholic beverages drowsiness will occur do not drive a motor vehicle or operate machinery", "Ask a doctor before use if": "a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland", "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.", "Keep out of reach of children": "In case of accidental overdose, contact a doctor or Poison Control Center right away. ", "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: 2026-02-15T12:01:26.028462 · Updated: 2026-03-14T23:01:25.991637