FDA Label for Diphenhydramine Hydrochloride
View Indications, Usage & Precautions
- DRUG FACTS
- OTC - PURPOSE
- USES
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS OR COMMENTS?
- OTHER
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Diphenhydramine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Walgreen Company. 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.
Drug Facts
Active ingredient (in each capsule)
Diphenhydramine HCI 25 mg
Otc - Purpose
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
Otc - Do Not Use
Do not use
to make a child sleepy
with any other product containing diphenhydramine, even one used on skin
Otc - Ask Doctor
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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use ifyou are taking sedatives or tranquilizers
Otc - When Using
When using this product
marked drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives and tranquilizers may increase drowsiness
use caution when driving a motor vehicle or operating machinery
excitability may occur, especially in children
Otc - Pregnancy Or Breast Feeding
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
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
take every 4 to 6 hours, or as directed by a doctor
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 |
Other Information
store in a dry place at 15° – 30°C (59° – 86°F)
protect from moisture
Inactive Ingredient
D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose and starch
Questions Or Comments?
1-800-925-4733
Other
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
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walgreens.com ©2021 Walgreen Co.
PRODUCT OF JAPAN
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING OR IF RED BAND AROUND CAPSULE IS BROKEN OR MISSING
†Our pharmacists recommend the Walgreens brand. We invite you to compare to national brands
††This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl®
Package Label.Principal Display Panel
Walgreens
Compare to the active ingredient in Benadryl® Allergy††
NDC 0363-9835-01
Relieves allergy symptoms
Allergy Relief
Diphenhysramine HCl 25 mg / Antihistamine
Relief of runny nose, sneezing, itchy throat & itchy, watery eyes
100 Capsules
* Please review the disclaimer below.