Active Ingredient (In Each Softgel)
Diphenhydramine HCl 25 mg
Sleep Aid
FDA Label NDC 51013-419
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Puracap Pharmaceutical Llc for the product Sleep Aid (NDC 51013-419). 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 softgel), purpose, uses, do not use, ask a doctor before use if you have, when using this product, overdose warning:, directions, 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
- with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
Ask A Doctor Before Use If You Have
- a breathing problem such as asthma, emphysema, or chronic bronchitis
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
- heart disease
When Using This Product
- avoid alcoholic beverages and other drugs that cause drowsiness
- drowsiness will occur
- be careful when driving a motor vehicle or operating machinery
Overdose Warning:
Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- take only one dose per day (24 hours) - see Overdose warning
| adults & children 12 yrs & over | 2 softgels at bedtime if needed or as directed by a doctor |
| childreb under 12 yrs | do not use |
Other Information
- store at 15°-30° C (59°-86° F)
- avoid excessive heat above 40° C (104° F) and high humidity
- protect from light
Inactive Ingredients
FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution, and white edible ink
Questions Or Comments?
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Principal Display Panel
Nighttime Sleep-Aid 96 SOFTGELS
NDC 51013-419-57
*Compare to the active ingredient in Vicks® ZzzQuil® LiquiCaps®
Carton Label (Cvs32 00)
* Please review the disclaimer below.
