Nighttime Sleep Aid — v1

Nighttime Sleep Aid

7 Views

Version

v1

Effective date

September 25, 2025

Original packager

Yes

Sections captured

17

Identifiers

Document ID
3f9bfb90-0d2f-16d1-e063-6394a90ac914
Set ID
7e8196ec-6695-40b0-a212-e14e9bb606fa
Application numbers
M010
Product NDCs
69517-004
Package NDCs
69517-004-03, 69517-004-06, 69517-004-10
Original packager NDCs

Names & Manufacturers

Brand names
Nighttime Sleep Aid
Generic names
DIPHENHYDRAMINE HCL
Manufacturer names
HealthLife of USA LLC
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
DIPHENHYDRAMINE HYDROCHLORIDE
Routes
ORAL
Pharmacologic class (PE)
Pharmacologic class (EPC)
Pharmacologic class (CS)
Mechanism of action

Other identifiers

NUI
RxCUI
UNII
TC2D6JAD40
UPC

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient (in each caplet) Diphenhydramine HCl 25 mg
Ask Doctor (1)

Sequence 1

ask a doctor before use if you have a breathing problem such as asthma, emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland heart disease
Ask Doctor Or Pharmacist (1)

Sequence 1

ask your doctor or pharmacist before use if you are taking sedative or tranquilizers or any other sleep-aid
Do Not Use (1)

Sequence 1

do not use: for children under 12 years of age with any other product containing diphenhydramine, even one used on skin with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
Dosage And Administration (1)

Sequence 1

Directions do not take more than directed(see overdose warning) adults and children 12 years of age and over:- take 2 caplets at bedtime if needed or as directed by a doctor children under 12 years of age:do not use
Inactive Ingredient (1)

Sequence 1

Inactive Ingredients Colloidal Silicon Dioxide, Croscarmellose Sodium, Dicalcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose (PH-102), Titanium dioxide, Brilliant Blue FCF Aluminum lack (FD&C Blue No. 1), Indico Carmel lake (FD&C Blue No. 2).
Indications And Usage (1)

Sequence 1

Uses: relief of occasional sleeplessness
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms
Other Safety Information (1)

Sequence 1

Other Information Each caplet contains: Calcium 23.52 mg store at controlled room temperature 25°C (77°F); excursions permitted between 15-30°C (59-86°F) read all product information before using
Package Label Principal Display Panel (3)

Sequence 1

Principal Display Panel-300 Caplets label

Sequence 2

Principal Display Panel-600 Caplets label-2

Sequence 3

Principal Display Panel-1000 Caplets label-3
Pregnancy Or Breast Feeding (1)

Sequence 1

If pregnant or breast-feeding, ask a health professional before use.
Purpose (1)

Sequence 1

Purpose Nighttime sleep-aid
Questions (1)

Sequence 1

Questions or comments? Call 1-844-832-1138 9AM – 5PM Monday - Friday
Spl Product Data Elements (1)

Sequence 1

Nighttime Sleep Aid Diphenhydramine HCl ANHYDROUS DIBASIC CALCIUM PHOSPHATE MICROCRYSTALLINE CELLULOSE CROSCARMELLOSE SODIUM SILICON DIOXIDE MAGNESIUM STEARATE FD&C BLUE NO. 1 FD&C BLUE NO. 2 TITANIUM DIOXIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE S25
Stop Use (1)

Sequence 1

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
Warnings (1)

Sequence 1

Warnings do not use: for children under 12 years of age with any other product containing diphenhydramine, even one used on skin with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products ask a doctor before use if you have a breathing problem such as asthma, emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland heart disease ask your doctor or pharmacist before use if you are taking sedative or tranquilizers or any other sleep-aid When using this product drowsiness will occur avoid alcoholic beverages and other drugs that cause drowsiness excitability may occur, especially in children alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating 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. Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms
When Using (1)

Sequence 1

When using this product drowsiness will occur avoid alcoholic beverages and other drugs that cause drowsiness excitability may occur, especially in children alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery

OpenFDA raw payload

{'application_number': ['M010'],
 'brand_name': ['Nighttime Sleep Aid'],
 'generic_name': ['DIPHENHYDRAMINE HCL'],
 'is_original_packager': [True],
 'manufacturer_name': ['HealthLife of USA LLC'],
 'package_ndc': ['69517-004-03', '69517-004-06', '69517-004-10'],
 'product_ndc': ['69517-004'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['ORAL'],
 'spl_id': ['3f9bfb90-0d2f-16d1-e063-6394a90ac914'],
 'spl_set_id': ['7e8196ec-6695-40b0-a212-e14e9bb606fa'],
 'substance_name': ['DIPHENHYDRAMINE HYDROCHLORIDE'],
 'unii': ['TC2D6JAD40']}