Active Ingredient (In Each Caplet)
Diphenhydramine HCl 50 mg
Diphenhydramine Hcl Tablet
FDA Label NDC 37835-852
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bi-mart for the product Diphenhydramine Hcl (NDC 37835-852). 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, use, 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, 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
helps reduce difficulty falling asleep
Do Not Use
- in children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
- with other antihistamines
Ask A Doctor Before Use If You Have
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- 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
- be careful when driveing a motor vehicle or operating 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.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- adults and children 12 years of age and over: take 1 caplet at bedtime if needed, or as directed by your doctor
- children under 12 years: do not use
Other Information
- each caplet contains:calcium 50 mg
- store at room temperature
- protect from moisture
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, dicalcium calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide, yellow iron oxide
Questions?
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