FDA Label for Diphenhydramine Hydrochloride
View Indications, Usage & Precautions
Diphenhydramine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Strive Pharmaceuticals Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Diphenhydramine HCl 50mg
Otc - Purpose
Nighttime Sleep-aid
Inactive Ingredient
FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, titanium dioxide
Dosage & Administration
- do not take more than directed (see overdose warning)
- adults and children 12 years of age and over: take 1 softgel at bedtime if needed, or as directed by doctor
- children under 12 years of age: do not use
Indications & Usage
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
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as asthma, emphysema or chronic bronchitis
- drowsiness will occur
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
- sleeplessness persist continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
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).
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