Active Ingredient (In Each Tablet)
Diphenhydramine HCl 25 mg
Allergy Relief Tablet, Film Coated
FDA Label NDC 55910-329
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dolgencorp, Llc for the product Allergy Relief (NDC 55910-329). 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
itching of the nose or throat
sneezing
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
glaucoma
a breathing problem such as emphysema or chronic bronchitis
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
store at 25°F (77°C); excursions permitted between 15°-30°C (59°-86°F)
use by expiration date on package
protect from moisture
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
Principal Display Panel
Since 1903
Rexall®
Allergy Relief
Diphenhydramine HCl 25 mg
Antihistamine
Relief of
• Sneezing
• Runny nose
• Itchy, watery eyes
• Itchy throat
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
50844 REV1016B32951
Visit us at: Rexall.com or call 1-866-4-REXALL
MANUFACTURED FOR DOLGENCORP, LLC
100 MISSION RIDGE, GOODLETTSVILLE, TN 37072 USA
Rexall 44-329 (Allergy Relief 1)
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