FDA Label for Diphenhist
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH CAPSULE)
- PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- IF PREGNANT OF BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Diphenhist Product Label
The following document was submitted to the FDA by the labeler of this product Rugby Laboratories. 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 Capsule)
Diphenhydramine HCl 25 mg
Purpose
Antihistamine
Uses
temporarily relieves these symptoms of the common cold:
- runny nose
- sneezing
- runny nose
- sneezing
- itching of the nose or throat
- itchy, watery eyes
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
Do Not Use
- with any other product containing diphenhydramine, even one used on skin
Ask A Doctor Before Use If You Have
a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers
When Using This Product
- excitability may occur, especially in children
marked drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when operating machinery or driving a motor vehicle
If Pregnant Of 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: 1-800-222-1222
Directions
- take every 4 to 6 hours, not more than 6 doses in 24 hours
adults and children 12 years of age and over | take 1 to 2 capsules |
children 6 to under 12 years of age | take 1 capsule |
children under 6 years of age | do not use this product in children under 6 years of age |
Other Information
- store at controlled room temperature 15°-30°C (59°-86°F) in a dry place
protect from moisture
- do not use if imprinted safety seal under cap is broken or missing
- do not use if red band around capsule is broken or missing
Inactive Ingredients
D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose and starch.
Questions Or Comments?
Call toll free 1-800-645-2158
Principal Display Panel
Diphenhist Capsules
Antihistamine
For the temporary relief of:
sneezing, itchy & watery eyes, runny nose & itchy throat
Diphenhydramine HCl 25 mg
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