Nighttime Sleep Aid Berry Flavor — v7

Nighttime Sleep Aid Berry Flavor

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Version

v7

Effective date

September 29, 2025

Original packager

Yes

Sections captured

18

Identifiers

Document ID
3fee6a6b-4566-0138-e063-6394a90abb54
Set ID
303d7651-9c8f-4a14-9f2c-7181fa0f003e
Application numbers
M012
Product NDCs
68163-730
Package NDCs
68163-730-06
Original packager NDCs

Names & Manufacturers

Brand names
Nighttime Sleep Aid Berry Flavor
Generic names
DIPHENHYDRAMINE HYDROCHLORIDE
Manufacturer names
Raritan Pharmaceuticals Inc
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
0368163730067

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient (in each 30 mL) Diphenhydramine HCl 50 mg
Ask Doctor (1)

Sequence 1

Ask a doctor before use if you have a breathing problem such as emphysema, or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland
Ask Doctor Or Pharmacist (1)

Sequence 1

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
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
Dosage And Administration (1)

Sequence 1

Directions take only one dose per day (24 hours) only use cup provided adults & children 12yrs & over One Dose 30 mL at bed time if needed or as directed by a doctor Children under 12 yrs do not use
Dosage And Administration Table (1)

Sequence 1

adults & children 12yrs & overOne Dose 30 mL at bed time if needed or as directed by a doctor
Children under 12 yrsdo not use
Inactive Ingredient (1)

Sequence 1

Inactive ingredients anhydrous citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.
Indications And Usage (1)

Sequence 1

Uses for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children.
Package Label Principal Display Panel (1)

Sequence 1

PRINCIPAL DISPLAY PANEL DRx CHOICE ® NDC 68163-730-06 Compare to in ZzzQuil® Nighttime Sleep-Aid active ingredient * Sleep-Aid Nighttime Diphenhydramine HCl Non-Habit Forming BERRY FLAVOR Naturally and Artificially Flavored Not for treating Cold or Flu See Warnings 6 FL OZ (177 mL) $1.99 AMAZING NEW VALUE! TAMPER EVIDENT: DO NOT USE IF PRINTED SHRINK BAND IS MISSING OR BROKEN *This product is not manufactured or distributed by Procter & Gamble, the distributor of ZzzQuil™ Nighttime Sleep-Aid. Manufactured by: Raritan Pharmaceuticals 8 Joanna Court, East Brunswick, NJ 08816 DRx Choice Sleep Aid Nighttime Berry Flavor
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
Spl Product Data Elements (1)

Sequence 1

Nighttime Sleep Aid Berry Flavor DIPHENHYDRAMINE HYDROCHLORIDE ANHYDROUS CITRIC ACID FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN POTASSIUM CITRATE WATER SODIUM BENZOATE SORBITOL SUCRALOSE XANTHAN GUM DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE Naturally and Artificially
Spl Unclassified Section (1)

Sequence 1

Drug Facts
Stop Use (1)

Sequence 1

Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness.
Storage And Handling (1)

Sequence 1

Other information each 30 mL dose contains: potassium 5 mg, sodium 10 mg store at room temperature
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 Ask a doctor before use if you have a breathing problem such as emphysema, or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product avoid alcoholic beverages Stop use and ask a doctor if sleeplessness persists continuously for more than two 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. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
When Using (1)

Sequence 1

When using this product avoid alcoholic beverages

OpenFDA raw payload

{'application_number': ['M012'],
 'brand_name': ['Nighttime Sleep Aid Berry Flavor'],
 'generic_name': ['DIPHENHYDRAMINE HYDROCHLORIDE'],
 'is_original_packager': [True],
 'manufacturer_name': ['Raritan Pharmaceuticals Inc'],
 'package_ndc': ['68163-730-06'],
 'product_ndc': ['68163-730'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['ORAL'],
 'spl_id': ['3fee6a6b-4566-0138-e063-6394a90abb54'],
 'spl_set_id': ['303d7651-9c8f-4a14-9f2c-7181fa0f003e'],
 'substance_name': ['DIPHENHYDRAMINE HYDROCHLORIDE'],
 'unii': ['TC2D6JAD40'],
 'upc': ['0368163730067']}