Kroger Nighttime Sleep Aid Caplet Tablet, Film Coated
FDA Label NDC 59450-601
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Kroger Co. for the product Kroger Nighttime Sleep Aid Caplet (NDC 59450-601). 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
• in 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.
Directions
| adults and children 12 years and over | take 2 caplets at bedtime if needed, or as directed by a doctor |
| children under 12 years | do not use |
Other Information
• each caplet contains: calcium 19 mg
• store at room temperature between 20°-25°C (68°-77°F). Avoid high humidity. Protect from light.
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?
call 1-800-632-6900
Packaging
Kroger-601 (5945060101)
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