Otc - Active Ingredient
Diphenhydramine HCl 50mg
Diphenhydramine Hydrochloride 50mg Capsule, Liquid Filled
FDA Label NDC 73629-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Amz789 Llc for the product Diphenhydramine Hydrochloride 50mg (NDC 73629-001). 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 otc - active ingredient, dosage & administration, use, indications & usage, otc - do not use, 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
Dosage & Administration
Dipheyhydramine HCl 50mg
Use
For relief of occasional sleeplessness
Indications & Usage
for relied of occasional sleeplessness
Otc - Do Not Use
for children under 12 years of age
with any other products containing diphenhydramine, even one used on skin
Ask A Doctor Or Pharmacist Before Use If
you have a breathing problem such as emphysema or chronic bronchitis, glaucoma, trouble urinating due to an enlarged prostate gland
you are taking sedatives or tranquilizers
When Using This Product
avoid alcholic drinks
Stop Use And Ask A Doctor If
sleeplessness presists continuously for more than 2 weeks. Insomnic may be a symptom of a series underlying medical illness
If Pregnant Or Breast-Feeding
ask a health professional before use
Otc - 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)
Direction
adults and children 12 years and over: 1 softgel at bedtime if needed, or as directed by a doctor
Inactive Ingredient
FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution, white ink
Package Label.Principal Display Panel
RxZell
SleepAid
Dyphenhydramine HCl 50mg
Non Habit-Forming
Easy to Swallow
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