Active Ingredient (In Each Capsule)
Diphenhydramine HCl 50 mg
Allergy Relief Tablet
FDA Label NDC 55910-450
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 Inc for the product Allergy Relief (NDC 55910-450). 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 capsule), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use, when using this product, 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 the other upper respiratory allergies:
■ runny nose ■ sneezing ■ itchy, watery eyes ■ itching of the nose or throat
Warnings
■ May cause excitability especially in children.
■ May cause marked drowsiness; alcohol, sedatives, and tranquilizres may increase the drowsiness effect.
Do Not Use
■ for children under 12 years of age ■ 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
■ trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use
if you are taking sedatives or tranquilizers.
When Using This Product
■ avoid alcoholic beverages ■ be careful when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
sleeplessness persists continuously for more than 2 weeks
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 Centre right away.
Directions
| adults and children 12 years and over | ■ take 1 tablet every 4 to 6 hours, or as directed by a doctor ■ do not take more than 6 tablets in 24 hours |
| children under 12 years | do not use |
Other Information
■ each tablet contains: calcium 36 mg ■ store between 20-25°C (68-77°F). Protect from light.
■ do not use if blister unit is torn or broken
Inactive Ingredients
croscarmellose sodium, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide
Questions Or Comments?
call toll-free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)
Other
†This product is not manufactured or distributed by the owners of Benadryl® Allergy Extra Strength.
THIS PRODUCT IS PACKAGED IN A CHILD-RESISTANT AND
TAMPER-EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.
KEEP OUTER CARTON FOR COMPLETE
WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY OLD EAST MAIN CO.
100 MISSION RIDGE GOODLETTSVILLE, TN 37072
MADE IN INDIA
CODE: TN/DRUGS/TN00002222/2006
100%
Satisfaction Guaranteed!
(888) 309-9030
949129331
L0000959
R0225
Carton
†Compare to the
active ingredient of
Benadryl® Allergy
Extra Strength
DG TM health
Extra Strength
Allergy Relief
diphenhydramine HCl Tablets, 50 mg
Antihistamine
Relieves:
• Sneezing • Itchy throat or nose
• Runny nose • Itchy, watery eyes
50
mg each
24 Tablets
Carton (Carton)
* Please review the disclaimer below.
