Active Ingredient (In Each 30 Ml)
Diphenhydramine HCl 50 mg
Nighttime Sleep Aid Solution
FDA Label NDC 37808-186
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by H E B for the product Nighttime Sleep Aid (NDC 37808-186). 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 (in each 30 ml), purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, 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
Uses
- 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
Ask A Doctor Before Use If You Have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- difficulty in urination due to an 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 2 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.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
- take only one dose per day (24 hours)
- only use the dose cup provided
adults & children 12 yrs & over | 30 mL at bed time if needed or as directed by a doctor |
children under 12 yrs | do not use |
Other Information
- each 30 mL contains: sodium 20 mg
- store at 20-25˚C (68-77˚F)
Inactive Ingredients
alcohol, anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, poloxamer 407, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate
Questions Or Comments?
1-800-719-9260
Package/Label Principal Display Panel
Compare to Vicks® ZzzQuil® active ingredient
Nighttime Sleep-Aid
Diphenhydramine HCl
50 mg per 30 mL
Helps You Fall Asleep
ALCOHOL 10%
Not for Treating Colds or Flu
Non-Habit Forming
Berry Flavor
12 FL OZ (355 mL)
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