Nighttime Sleep-Aid

Manufacturer
AptaPharma Inc.
Effective date
2023-12-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:06:09

Label at a glance#

ProductNighttime Sleep-Aid Non-Habit Forming
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure16 sections

Indications and uses

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

Dosage and administration

■ take only as recommended ■ Use dosage cup or tablespoon        Age                                     Dose Adults & children 12          One Dose = 2 tablespoons (30 mL) at bed years & over                    time if needed or as directed by a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each 30 mL dose cup or 2 tablespoons)
Diphenhydramine HCI 50 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use ■ for children under 12 years of age.
■ with any other product containing diphenhydramine, even one used on skin
■ with any other drugs that cause drowsiness such as antihistamines and nighttime cough, cold/flu products

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

■ heart disease
■ trouble urinating due to enlarged prostrate gland
■ glaucoma
■ a breathing problem such as asthma, emphysema or chronic bronchitis

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking
sedatives or tranquilizers or any other sleep aid

When using this product

OTC - WHEN USING SECTION

■ do not use more than directed
■ avoid alcoholic beverages and other drugs that cause drowsiness
■ drowsiness will occur
■ be careful when driving a motor vehicle or operating machinery
■ alcohol, sedatives, and tranquilizers may increase drowsiness

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 serious underlying medical illness.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

■ take only as recommended
■ Use dosage cup or tablespoon

       Age                                     Dose
Adults & children 12          One Dose = 2 tablespoons (30 mL) at bed
years & over                    time if needed or as directed by a doctor

Other information

OTHER SAFETY INFORMATION

■ each 30 mL dose (2 tablespoons) contains: sodium 23 mg
■ dosage cup provided
■ store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, FD&C Blue #1, FD&C Red #40, flavor, high fructose corn
syrup, poloxamer 407, propylene glycol, purified water, sodium
benzoate, sodium citrate, sodium saccharin

OTC - QUESTIONS SECTION

Questions? Call weekdays from 9:30 AM to 4:30 PM EST at
1-877-798-5944

Nighttime Sleep-Aid Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 76281-522-28

AP SAFE

*COMPARE TO the
active ingredient in ZzzQUIL™
NIGHTTIME SLEEP-AID

Nighttime
Sleep-Aid

Diphenhydramine HCI

Non-Habit Forming
Not for treating Cold or Flu

Warming Berry
Flavored Liquid

12 FL OZ (354 mL)

DO NOTUSE IF IMPRINTEDSHRINK BAND IS MISSING OR BROKEN
Failure to follow these warnings could result in serious consequences

Drug Facts

Active ingredient                                                           Purpose
(in each 30 mL dose cup or 2 tablespoons)
Diphenhydramine HCI 50 mg…………………………Nighttime sleep-aid

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

Warnings
Do not use ■ for children under 12 years of age.
■ with any other product containing diphenhydramine, even one
used on skin
■ with any other drugs that cause drowsiness such as
antihistamines and nighttime cough, cold/flu products

Ask a doctor before use if you have
■ heart disease
■ trouble urinating due to enlarged prostrate gland
■ glaucoma
■ a breathing problem such as asthma, emphysema or chronic
bronchitis

Ask a doctor or pharmacist before use if you are taking
sedatives or tranquilizers or any other sleep aid

When using this product
■ do not use more than directed
■ avoid alcoholic beverages and other drugs that cause drowsiness
■ drowsiness will occur
■ be careful when driving a motor vehicle or operating machinery
■ alcohol, sedatives, and tranquilizers may increase drowsiness

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

Drug Facts(continued)

Directions
■ take only as recommended
■ Use dosage cup or tablespoon

        Age                                         Dose
Adults & children 12           One Dose = 2 tablespoons (30 mL) at bed
years & over                     time if needed or as directed by a doctor

Other information
■ each 30 mL dose (2 tablespoons) contains: sodium 23 mg
■ dosage cup provided
■ store at room temperature

Inactive ingredients
citric acid, FD&C Blue #1, FD&C Red #40, flavor, high fructose corn
syrup, poloxamer 407, propylene glycol, purified water, sodium
benzoate, sodium citrate, sodium saccharin

Questions? Call weekdays from 9:30 AM to 4:30 PM EST at
1-877-798-5944

*This product is not manufactured or distributed by Procter
& Gamble, owner of the registered trademark ZzzQuil™

Manufactured by: AptaPharma Inc.,
1533 Union Ave.,
Pennsauken, NJ 08110

AP-LR-10

NigTimeSleepAidNigTimeSleepAid

NigTimeSleepAidNigTimeSleepAid

6 OZ

6 oz label6 oz label6 oz label6 oz label

4 OZ

4 oz label4 oz label4 oz label4 oz label

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSN3
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCD3
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSY3
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76281-522-24Nighttime Sleep-AidNon-Habit Forming118 mL in 1 BOTTLELIQUID1183
76281-522-25Nighttime Sleep-AidNon-Habit Forming177 mL in 1 BOTTLELIQUID1773
76281-522-28Nighttime Sleep-AidNon-Habit Forming354 mL in 1 BOTTLELIQUID3543

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76281-522NIGHTTIME SLEEP-AID NON-HABIT FORMING (DIPHENHYDRAMINE HCI) LIQUID [APTAPHARMA INC.]3Current NDC, Legacy NDC, 3 package rows20231231_ed0ba7aa-e794-43da-b576-6b9945bf7477.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76281-52276281-522-28, 76281-522-25, 76281-522-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML · Source PDF

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
Nighttime Sleep-Aid Non-Habit FormingDIPHENHYDRAMINE HCIAptaPharma Inc.ed0ba7aa-e794-43da-b576-6b9945bf74772023-12-30WarningsExact identifier
ndc (package): 76281-522-25
ndc (package): 76281-522-28
ndc (package): 76281-522-24
ndc (product): 76281-522
ndc11 (package): 76281052228
ndc11 (package): 76281052225
ndc11 (package): 76281052224
spl id: f1654da1-64f7-4c2b-9201-3a7af430ba37
spl set id: ed0ba7aa-e794-43da-b576-6b9945bf7477

Reported adverse events (FAERS/openFDA)#

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