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 25mg
Otc - Purpose
Antihistamine
Inactive Ingredient
polyethylene glycol 400, propylene glycol, gelatin, glycerin, sorbitol 70%, povidone k-30
Dosage & Administration
If needed, repeat dose every 4 to 6 hours donot take more than 6 doses in 24 hours
Age | Daily dosage |
Adults and children 12 years of age or older | 1 to 2 softgel |
Children 6 to under 12 years | 1 softgel |
Children under 6 years of age | do not use this product |
Indications & Usage
temporarily relieves these symptoms due to hay fever or other respiratory allergies:
- runny nose
- itching of the nose or throat
- itchy, watery eyes
- runny nose
- sneezing
temporarily relieves these symptoms due to the common cold:
Warnings
Do not use
- to make a child sleepy
- 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 emphysema or chronic bronchitis
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, expecially in children
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
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 between 20-25°C (68-77°F), Excursions permitted between 15°C-30°C (59-86°F).
- 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.