Active Ingredient
Diphenhydramine HCl 25 mg
Allergy Relief Tablet, Film Coated
FDA Label NDC 29485-9285
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lil' Drug Store Products, Inc. for the product Allergy Relief (NDC 29485-9285). 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 active ingredient, purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 tranquilizers or sedatives.
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 Or 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, or as directed by a doctor
- do not take more than 6 doses in 24 hours
adults and children 12 years and over | take 1 to 2 tablets |
| children 6 to under 12 years | take 1 tablet |
| children under 6 years | do not use |
Other Information
- each tablet may contain: calcium 25 mg
- store at room temperature 68°-77°F (20°-25°C)
- protect from light and moisture
Inactive Ingredients
carnauba wax
may contain
, colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphateQuestions Or Comments
call toll-free 800-351-2000 (M-F 8:00 AM-4:30 PM CST)
Other
* This product is not manufactured or distributed by
JOHNSON & JOHNSON CONSUMER INC,
McNeil Consumer Healthcare Division,
distributor of Benadryl® Allergy ULTRATABS®
Distributed by:
Lil’ Drug Store Products, Inc.
Cedar Rapids, IA 52404
Package Label.Principal Display Panel
COMPARE TO THE ACTIVE INGREDIENTS IN
Benadryl® Allergy ULTRATABS®
Allergy Relief
Diphenhydramine HCl 25 mg,
Antihistamine
Relieves Symptoms of
Hay Fever, Common Cold and [tablet image here]
Other Upper Respiratory Allergies actual size
2 TABLETS IN EACH PACKET
* Please review the disclaimer below.
