Drug Facts
Active ingredient (in each 30 mL dose cup)
Diphenhydramine HCl 50mg
Diphenhydramine Hcl Liquid
FDA Label NDC 37835-519
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 37835-519). 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, purpose, uses, warnings, 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
Nightime sleep-aid
Uses
• for the relief of occasional sleeplessness
• reduces time to fall asleep if you have difficulty falling asleep
Warnings
Do not use
• for children under 12 years of age
• with any other product containing diphenhydramine, even one used on skin
• with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
Ask A Doctor Before Use If You Have
• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• difficulty in urination due to enlargement of the prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers
When Using This Product
avoid alcoholic beverages
Stop Use And Ask A Doctor If
sleeplessness persists continuosly for more than 2 weeks. Insomnia may be a symptom of serious underlying medical ilness.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of The Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
• take only one dose (30 mL) per day (24 hours)
• only use dose cup provided
| Age | Dose |
| adults and children 12 years and over | 30 mL at bedtime if needed or as directed by a doctor |
| children under 12 years | do not use |
Other Information
•
each 30 mL dose cup contains:sodium 24 mg
• store between 15-30°C (59-86°F).
Inactive Ingredients
anhydrous citric acid, FD&C Blue #1, FD&C Red #40, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose.
Questions Or Comments?
1-844-912-4012
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