FDA.reportPublic FDA data

Dye Free Sleep Aid

Manufacturer
Walgreen Company | LNK International, Inc.
Effective date
2021-09-09
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:36:42

Label at a glance#

ProductDye Free Sleep Aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

for relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep

Dosage and administration

do not take more than directed  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

Storage and handling

each caplet contains: calcium 30 mg  protect from moisture store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

  • for relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

avoid alcoholic beverages.

Stop use and ask a doctor if

OTC - STOP USE SECTION

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed 
  • 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

STORAGE AND HANDLING SECTION

  • each caplet contains: calcium 30 mg 
  • protect from moisture
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Walgreens

Compare to Simply Sleep® active ingredient††

NDC 0363-6270-12

Dye-Free Sleep Aid

DIPHENHYDRAMINE HCl 25 mg / NIGHTTIME SLEEP AID

DYE FREE   NIGHTTIME   MINI CAPLETS

• For a restful night's sleep   • Does not contain pain reliever
• Safe, non-habit forming

100  MINI-CAPLETS

Actual Size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Walgreens Pharmacist Recommeneded
Walgreens Pharmacist Survey

††This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Simply Sleep®.

50844      REV1019A62712

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED
walgreens.com    ©2018 Walgreen Co.

44-62744-627

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-62700363-6270-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
STARCH, CORNO8232NY3SJIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2660b283-dca9-4d11-b0b3-835e7e2896a4e8d45ad1-8531-4b0c-84bd-554a1c8cb9d92021-09-09WarningsExact identifier
spl id: 2660b283-dca9-4d11-b0b3-835e7e2896a4
spl set id: e8d45ad1-8531-4b0c-84bd-554a1c8cb9d9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.