Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameDIPHENHYDRAMINE HYDROCHLORIDE
Labeler / manufacturerRaritan Pharmaceuticals Inc
RouteORAL
Drug classDrug class not supplied in source label
Product NDC68163-730
Label effective date2026-09-09
Official product label reference
Nighttime Sleep Aid Berry Flavor — Raritan Pharmaceuticals Inc
This page contains 15 source sections for DIPHENHYDRAMINE HYDROCHLORIDE, oral route. Label set 303d7651-9c8f-4a14-9f2c-7181fa0f003e, version 8.
Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.
Uses described in the label
Uses ▪ for the relief of occasional sleeplessness ▪ reduces time to fall asleep if you have difficulty falling asleep
Purpose
Purpose Nighttime sleep-aid
Dosage and administration — label text
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
Table text from source:
| 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
Warnings
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.
Unclassified section
Drug Facts
Active ingredient
Active ingredient (in each 30 mL) Diphenhydramine HCl 50 mg
Do not use
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
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
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
While using this medicine
When using this product ▪ avoid alcoholic beverages
When to stop use and seek help
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.
Pregnancy or breast feeding
If pregnant or breast-feeding , ask a health professional before use.
Child safety
Keep out of reach of children.
Storage and handling
Other information ▪ each 30 mL dose contains: potassium 5 mg, sodium 10 mg ▪ store at room temperature
The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.