FDA Label for Nighttime Sleep-aid
View Indications, Usage & Precautions
Nighttime Sleep-aid Product Label
The following document was submitted to the FDA by the labeler of this product Northeast Pharma. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Caplet)
Diphenhydramine Hydrochloride 25mg
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?
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Package Label
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