Nighttime Sleep Aid Tablet, Coated
FDA Label NDC 70692-151
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strive Pharmaceuticals Inc. for the product Nighttime Sleep Aid (NDC 70692-151). 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 caplet), purpose, use, 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 Caplet)
Diphenhydramine HCl 25 mg
Purpose
Nighttime sleep-aid
Use
• for relief of occasional sleeplessness
Warnings
Do not use
• for children under 12 years of age
• with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
• 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
• drowsiness will occur
• do not drive a motor vehicle or operate machinery
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.
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
| adults and children 12 years of age and over | take 2 caplets at bedtime if needed, or as directed by a doctor |
| children under 12 years of age | do not use |
Other Information
• each caplet contains: calcium 19 mg
• store at room temperature between 20°-25°C (68°-77°F)
• avoid excessive heat, light and moisture.
Inactive Ingredients
croscarmellose sodium, dicalcium phosphate, FD&C blue #1, FD&C blue #2, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide
Questions Or Comments?
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Packaging
Strive-151 (7069215146 1)
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