Active Ingredient (In Each Tablet)
Diphenhydramine HCl 25 mg
Allergy Relief Tablet, Film Coated
FDA Label NDC 55319-329
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Family Dollar Services Inc for the product Allergy Relief (NDC 55319-329). 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 (in each tablet), 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 or breast-feeding,, 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
itchy, watery eyes
sneezing
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
- difficulty in urination due to enlargement of the 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 beverages
alcohol, sedatives, and tranquilizers may increase drowsiness
use caution 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 (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 times in 24 hours
adults and children 12 | 1 to 2 tablets |
| children 6 to under 12 years | 1 tablet |
| children under 6 years | do not use |
Other Information
each tablet contains: calcium 30 mg
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
protect from moisture
see end flap for expiration date and lot number
Inactive Ingredients
corn starch, D&C red #27 aluminum lake, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide
Questions Or Comments?
1-800-426-9391
Principal Display Panel
FAMILY wellness™
COMPARE TO THE ACTIVE INGREDIENT IN BENADRYL® ALLERGY ULTRATAB® TABLETS*
Allergy Relief
Diphenhydramine HCl 25 mg
Antihistamine
For Relief of:
• Runny Nose
• Itchy Throat
• Sneezing
• Itchy, Watery Eyes
48 COATED MINITABS
(SMALL SIZE TABLETS)
ACTUAL SIZE
OTC
network
DISTRIBUTED BY: MIDWOOD BRANDS, LLC
10611 MONROE ROAD., MATTHEWS, NC 28105
NOT 100% SATISFIED?
Return package and unused product within 30 days to any
Family Dollar store for a refund (with receipt) or exchange.
*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl® Allergy ULTRATAB® Tablets.
50844 REV1016E32922
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
* Please review the disclaimer below.
