Nighttime Sleep Aid
FDA Label NDC 68210-4195
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals Llc for the product Nighttime Sleep Aid (NDC 68210-4195). 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 tablet), purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Tablet)
Diphenhydramine Hydrochloride 25 mg
Purpose
Nighttime sleep-aid
Uses
• for the relief of occasional sleeplessness • reduces time to fall asleep if you have difficulty falling asleep
Warnings
Otc - Do Not Use
Do not use • for children under 12 years of age • with any other product containing diphenhydramine, even one used on skin.
Otc - Ask Doctor
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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
Otc - When Using
When using this product • avoid alcoholic beverages
Otc - Stop Use
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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)
| adults & children 12 years & over | take 2 softgels at bedtime if needed or as directed by a doctor |
| children under 12 years | do not use |
Other Information
• store at 20-25° C (68-77° 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, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide
Questions Or Comments?
1-888-333-9792
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Distributed By:
Spirit Pharmaceuticals, LLC
Ronkonkoma, NY 11779
Made in India
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