Drug Facts
Active ingredient (in each banded capsule)
Diphenhydramine HCI 25 mg
Diphenhydramine Hydrochloride Capsule
FDA Label NDC 70000-0598
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Leader/ Cardinal Health 110, Inc. for the product Diphenhydramine Hydrochloride (NDC 70000-0598). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, otc - purpose, uses, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes n itching of the nose or throat
- runny nose
- sneezing
temporarily relieves these symptoms due to the common cold:
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 if you 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
- be careful 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 right away (1-800-222-1222).
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 this product in children under 6 years of age
Other Information
- store in a dry place at 15° – 30°C (59° – 86°F)
Inactive Ingredient
corn starch, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, sodium lauryl sulfate
Questions Or Comments?
1-800-231-4670
Other
DO NOT USE IF PRODUCT APPEARS TO BE TAMPERED WITH OR IF BLISTER UNIT IS BROKEN OR TORN. DO NOT USE IF RED CAPSULE BAND IS BROKEN OR MISSING. KEEP THIS BOX FOR IMPORTANT INFORMATION.
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313
Product of China.
*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl® Allergy.
Package Label.Principal Display Panel
Allergy Capsules
Diphenhydramine HCl, 25 mg | Antihistamine
For Allergy Relief:
Runny Nose
Itchy Throat
Sneezing
Itchy, Watery Eyes
COMPARE TO BENADRYL® ALLERGY active ingredient*
24 Capsules
* Please review the disclaimer below.
