FDA Label for Diphenhydramine Hcl 25 Mg
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH CAPLET)
- PURPOSE
- USES
- WARNINGS
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Diphenhydramine Hcl 25 Mg Product Label
The following document was submitted to the FDA by the labeler of this product Reliable 1 Laboratories Llc. 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.
Other
Drug Facts
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark BENADRYL®
Distributed by: Reliable 1 Laboratories LLC
Valley Stream, NY 11580
Active Ingredient (In Each Caplet)
Diphenhydramine HCL 25 mg
Purpose
Antihistamine
Uses
temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy nose or throat
- itchy, watery eyes
Warnings
Do not use
- with any other product containing diphenhydramine, even one use on skin
- to make a child sleepy
Otc - Ask Doctor
Ask a doctor before use if you have
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breating problem such as emphysema or chronic bronchitis
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
Drug Facts continued on back of label
Otc - When Using
When using this product
- you may get very drowsy
- avoid alcoholic drinks
- alcohol, sedatives, & 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 breat-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical helo or contact a Poison Control Center right away.
Directions
- take every 4-6 hours
- do not take more than 6 doses in 24 hours
adults and children 12 years and over | 1 to 2 caplets |
children 6 to under 12 years | 1 caplet |
children under 6 years | do not use |
Other Information
- each caplet contains: calcium 45 mg
- store at room temperature
- protect from moisture
Inactive Ingredients
croscarmellose sodium, D&C red #27, dicalcium phosphate, HPMC, magnesium stearate, microcrystalline cellulose, PEG, titanium dioxide
Questions Or Comments?
call 516-341-0666, 8:30 am - 4:30 pmET, Monday - Friday
Package Label.Principal Display Panel
NDC 69618-025-01
Diphenhydramine HCL 25 mg
ANTIHISTAMINE
100 CAPLETS
*Compare to Active Ingredient in BENADRYL® ALLERGY
* Please review the disclaimer below.