Otc - Active Ingredient
Diphenhydramine HCl 25 mg
Diphenhydramine Hydrochloride Capsule, Liquid Filled
FDA Label NDC 73629-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Amz789 Llc for the product Diphenhydramine Hydrochloride (NDC 73629-007). 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 otc - active ingredient, dosage & administration, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Dosage & Administration
Diphenhydramine HCl 25 mg
Otc - Purpose
Nighttime sleep-aid
Indications & Usage
for the relief of occasional sleeplessness
reduces time to fall asleep if you have difficulty falling asleep
Warnings
Warnings
Otc - 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
- do not use with NyQuil
Otc - Ask Doctor/Pharmacist
- a breathing problem such as asthma, emphysema, or chronic bronchitis
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
- heart disease
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep aid
Otc - When Using
- avoid alcoholic beverages and other drugs that cause drowsiness
- drowsiness will occur
- be careful when driving a motor vehicle or operating machinery
Otc - Stop Use
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage Forms & Strengths
take only one dose per day (24 hours) - see Overdose warning
| adults & Children 12 yrs & over | One dose = TWO 25mg softgels (50mg) at bedtime if needed or as directed by a doctor |
Inactive Ingredient
FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special and white edible ink
Package Label.Principal Display Panel
Display Panel (Labelimage)
* Please review the disclaimer below.
