Active Ingredient (In Each Caplet)
Diphenhydramine HCl 25 mg
Betr Sleep Aid Tablet, Film Coated
FDA Label NDC 80267-431
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Live Betr Llc for the product Betr Sleep Aid (NDC 80267-431). 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
for relief of occasional sleeplessness
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 may 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
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 15 mg
- store at 20-25°C (68-77°F). Avoid high humidity. Protect from light.
- do not use if blister unit is broken or torn
Inactive Ingredients
carnauba wax, crospovidone, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide
Questions Or Comments?
1-800-719-9260
Principal Display Panel
sleep aid
DIPHENHYDRAMINE HCl 25mg
Actual Size
Nighttime Sleep Aid
Helps you fall asleep
Does not contain pain reliever
48 CAPLETS
Sleep Aid Image (Image 01)
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