Nighttime Sleep-aid Softgel Capsule, Liquid Filled
FDA Label NDC 51316-779
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy, Inc for the product Nighttime Sleep-aid Softgel (NDC 51316-779). 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 softgel), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Softgel)
Diphenhydramine HCl 25 mg
Purpose
Nighttime sleep-aid
Uses
• for relief of occasional sleeplessness
• reduces time to fall asleep if you have difficulty falling asleep
Warnings
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 • glaucoma • heart diseases • a breathing problem such as emphysema, asthma, or chronic bronchitis • difficulty in urination due to enlargement of the prostate gland
Ask a doctor or pharmacist before use if you are taking sedatives, tranquilizers, or any other sleep aid
When using this product avoid alcoholic beverages and other drugs that cause drowsiness. Be careful when driving a motor vehicle or operating machinery
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
Directions
• take only one dose per day (24 hours)
• adults and children 12 years and 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)
Inactive Ingredients
FD&C blue#1, FD&C red#40, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, purified water, sorbitol sorbitan solution, white ink
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