Active Ingredient (In Each Caplet)
Diphenhydramine Hydrochloride 25mg
Nighttime Sleep-aid Tablet
FDA Label NDC 80136-785
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Northeast Pharma for the product Nighttime Sleep-aid (NDC 80136-785). 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 caplet), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, 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
- relieves occasional sleeplessness
Warnings
Do not use
• in children under 12 years
• with any other product containing diphenhydramine, including one used
on skin
Ask a doctor before use if you have
• a breathing problem such as emphysema, asthma, 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 beverages
• 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 two 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. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
• adults and children 12 years and over: take two caplets at bedtime if needed, or as directed by a doctor
• do not exceed recommended dose
Other Information
- each caplet contains: calcium 85mg
- store at 20°C-25°C (68°F-77°F)
- Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
Inactive Ingredients
calcium phosphate, croscarmellose sodium, magnesium stearate,
microcrystalline cellulose, silica.
Questions Or Comments?
1-800-540-3765
Package Label
1 (Hpc785)
* Please review the disclaimer below.
