Active Ingredient(S)
Diphenhydramine HCl 50 mg (in each 30 mL)
Nighttime Sleep Aid Liquid
FDA Label NDC 69168-486
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Nighttime Sleep Aid (NDC 69168-486). 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 active ingredient(s), purpose, use(s), do not use, ask a doctor before use if you, ask a doctor or pharmacist before use if, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Nighttime sleep-aid
Use(S)
- for the relief of occasional sleeplessness
- reduces time to fall asleep if you have difficulty falling asleep
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 product
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
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 2 weeks. Insomnia may be a symptom of a serious underlying medical
illness.
If Pregnant Or Breastfeeding,
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 (1-800-222-1222) right away.
Directions
• take only one dose (30 mL) per day (24 hours)
• only use dose cup provided
| Age | Dose |
| 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 Information
• each 30 mL dose cup contains: sodium 24 mg
• store between 15-30°C (59-86°F).
TAMPER EVIDENT: DO NOT USE IF PRINTED NECK WRAP IS BROKEN OR MISSING
Inactive Ingredients
anhydrous citric acid, FD&C Blue #1, FD&C
Red #40, flavor, glycerin, menthol, propylene glycol, purified water,
sodium benzoate, sodium citrate, sorbitol, sucralose.
Questions/Comments
Call 1-888-952-0050
(Monday-Friday 9 AM – 5 PM EST)
Principal Display Panel
Nighttime Sleep Aid
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