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Drug Facts
Nighttime Sleep Aid Liquid
FDA Label NDC 68391-793
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bjwc (berkley & Jensen / Bj's) for the product Nighttime Sleep Aid (NDC 68391-793). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient (in each 30 mL dose cup)
Diphenhydramine HCl 50 mg
Otc - Purpose
Purpose
Nighttime sleep-aid
Indications & Usage
Uses
- for the relief of occasional sleeplessness
- reduces time to fall asleep if you have difficulty falling asleep
Warnings
Warnings
Otc - Do Not Use
Do not use
- for children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
Otc - Ask Doctor
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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
Otc - When Using
When using this product
- avoid alcoholic beverages
Otc - Stop Use
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Dosage & Administration
Directions
- take only one dose (30 mL) per day (24 hours)
- only use the dose cup provided
adults & children 12 yrs & over | 30 mL at bedtime if needed or as directed by a doctor |
children under 12 yrs | do not use |
Other Safety Information
Other information
- each 30 mL dose cup contains: sodium 23 mg
- store at no greater than 25°C
Inactive Ingredient
Inactive ingredients anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, sucrose, xanthan gum
Otc - Questions
Questions or comments? Call 1-877-290-4008
Package Label.Principal Display Panel
793L12 fl oz label
793L 36 fl oz carton
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