FDA Label for Diphenhydramine Hcl
View Indications, Usage & Precautions
Diphenhydramine Hcl Product Label
The following document was submitted to the FDA by the labeler of this product Innovida Pharmaeutique Corporation. 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.
Active Ingredient (In Each Tablet)
Diphenhydramine HCl 25 mg
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- sneezing
- itching of the nose or throat
- 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
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic beverages
- use caution when driving a motor vehicle or operating machinery
- excitability may occur, especially 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.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not take more than directed
- take every 4 to 6 hours, or as directed by a doctor
- do not take more than 6 times in 24 hours
| adults and children 12 years and over | 1 to 2 tablets |
| children 6 to under 12 years | 1 tablet |
| children under 6 years | do not use |
Other Information
- each tablet contains: calcium 30 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- protect from moisture
- use by expiration date on package
Inactive Ingredients
corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide
Product Label
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