Otc - Active Ingredient
Diphenhydramine HCl 25mg
Diphenhydramine Hydrochloride
FDA Label NDC 70692-784
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strive Pharmaceuticals Inc. for the product Diphenhydramine Hydrochloride (NDC 70692-784). 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, otc - purpose, inactive ingredient, dosage & administration, indications & usage, warnings, otc - keep out of reach of children, overdosage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sleep-aid
Inactive Ingredient
polyethylene glycol, propylene glycol, FD&C blue # 1, FD&C red # 40, gelatin, glycerin, sorbitol 70%, povidone, purified water.
Dosage & Administration
- do not take more than directed (see overdose warning)
- adults and children 12 years of age and over: take 2 softgels at bedtime if needed or as directed by doctor
- children under 12 years of age: do not use
Indications & Usage
- helps fall asleep faster
- for relief of occasional sleeplessness
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 night-time cold/flu products
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as asthma, emphysema or chronic bronchitis
- heart disease
- drowsiness may occur
- avoid alcoholic drinks and other drugs that cause drowsiness
- sleeplessness persist continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
- excitability may occur, especially in children
- alcohol, sedatives and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep-aid
When using this product
Stop use and ask a doctor if
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
Other Safety Information
- store at room temperature between 20-25°C (68-77°F).
- avoid excessive heat, cold and humidity.
- TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
* Please review the disclaimer below.
