Active Ingredient (In Each Caplet)
Diphenhydramine HCl 25 mg
Nighttime Sleep Aid Tablet
FDA Label NDC 11673-496
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Target Corporation for the product Nighttime Sleep Aid (NDC 11673-496). 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, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, 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
■ for relief of occasional sleeplessness
Warnings
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 prostrate 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.
Keep Out Of Reach Of Children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
Do not take more than directed.
See overdose warning
| 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 25 mg
■ store between 20-25°C (68-77°F). Avoid high humidity. Protect from light
Inactive Ingredients
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide
Questions Or Comments?
Call 1-800-910-6874
Package Label.Principal Display Panel
241r-target-diphenhydramine-100s-label (241r Target Diphenhydramine 100s Label)
241r-target-diphenhydramine-100s-ifc (241r Target Diphenhydramine 100s Ifc)
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