Active Ingredient(S)
Diphenhydramine HCl 25 mg
Diphenhydramine Hcl 25mg Tablet, Coated
FDA Label NDC 69168-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Diphenhydramine Hcl 25mg (NDC 69168-002). 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(s), purpose, use(s), do not use, ask a doctor before use if, ask a doctor or pharmacist before use if, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Nighttime sleep aid
Use(S)
for relief of occasional sleeplessness
Do Not Use
- In children under 12 years of age
- With any other product containing diphenydramine, even one used on skin
Ask A Doctor Before Use If
- 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 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 2 weeks. Insomnia may be a symptom of
a serious underlying medical illness.
Pregnancy/Breastfeeding
If pregnant or breast-feeding, ask a health professional before use.
Keep Out Of Reach Of Children
In case of accidental overdose, contact a doctor or 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 of age: do not use
Other Information
- store at room temperature 20°– 25°C (68°– 77°F)
- do not use if blister unit is torn or open
- you may report side effects to 1-888-952-0050
Inactive Ingredients
croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, lactose, magnesium
stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide
Principal Display Panel
Sleep Aid (Greenfield Sleep Aid 1)
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