Active Ingredient(S)
Diphenhydramine HCl 50mg
Nighttime Sleep Aid Capsule, Liquid Filled
FDA Label NDC 85828-410
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 for the product Nighttime Sleep Aid (NDC 85828-410). 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 if you have, 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 relief of occasional sleeplessness
Do Not Use If You Have
for children under 12 years of age
- with any other products containing diphenhydramine, even one used on skin
Ask A Doctor Before Use If You
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If
you are taking sedatives or tranquilizers
When Using This Product
avoid alcoholic drinks
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
Adults and children 12 years and over: 1 softgel (50mg) at bedtime if needed, or as directed by a doctor
Other Information
store at room temperature 15° to 30°C (59° to 86°F)
avoid excessive heat
Inactive Ingredients
FD&C blue #1,gelatin, glycerin, polyethylene glycol, purified
water, sorbitol sorbitan solution, white ink
Questions/Comments
Call 1-877-290-4008
Principal Display Panel
Label (Nighttime Sleep Aid 1)
Carton (Nighttime Sleep Aid 2)
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