Drug Facts
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Nighttime Sleep Aid Liquid
FDA Label NDC 85828-793
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Grocery Outlet, Inc. for the product Nighttime Sleep Aid (NDC 85828-793). 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 drug facts, active ingredient (in each 30 ml dose cup), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each 30 Ml Dose Cup)
Diphenhydramine HCl 50 mg
Purpose
Nighttime sleep-aid
Uses
- for the relief of occasional sleeplessness
- reduces time to fall asleep if you have difficulty falling asleep
Warnings
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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 2 weeks. Insomnia may be a symptom of a 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 (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 Information
- each 30 mL dose cup contains: sodium 23 mg
- store at no greater than 25°C
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
Questions Or Comments?
Call 1-877-290-4008
Package Label.Principal Display Panel
Diphenhydramine-liquid-12oz (Diphenhydramine Liquid 12oz)
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