FDA Label for Diphenhydramine Hydrochloride
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH BANDED 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 - 25 MG CAPSULE BLISTER PACK CARTON LABEL
Diphenhydramine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Central Texas Community Health Centers. 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 Banded Capsule)
Diphenhydramine HCl 25 mg
Purpose
Antihistamine
Uses
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
- temporarily relieves these symptoms due to the common cold:
- runny nose
- sneezing
Do Not Use
- to make a child sleepy
- 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
- 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, especially in children
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.
Directions
- take every 4 to 6 hours
- do not take more than 6 doses in 24 hours
| adults and children 12 years of age and over | 1 to 2 capsules |
| children 6 to under 12 years of age | 1 capsule |
| children under 6 years of age | do not use this product in children under 6 years of age |
Other Information
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
- protect from moisture
Inactive Ingredients
butylparaben, corn starch, D&C red #28, edible ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, silica gel
Questions Or Comments?
1-800-616-2471
Principal Display Panel - 25 Mg Capsule Blister Pack Carton Label
CommUnityCare Federally Qualified Health Centers
DIPHENHYDRAMINE
25mg/24 Caps
Date:
Name:
Dr.
USE AS DIRECTED.
123456
1/1/01
DIPHENHYDRAMINE 25mg/24 CAPS NDC 76413-306-24
Batch: 123456
Lot: 123456
Exp: 1/1/01
MAJOR
Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.
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