FDA Label for Allergy Relief
View Indications, Usage & Precautions
Allergy Relief Product Label
The following document was submitted to the FDA by the labeler of this product Twin Med 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.
Active Ingredient (In Each Caplet)
Diphenhydramine HCl 25 mg
Purpose
Antihistamine
Uses
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- temporarily relieves these symptoms of the common cold:
o runny nose
o sneezing
o itchy, watery eyes
o itchy nose or throat
o runny nose
o sneezing
Warnings
do not use
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
- trouble urinating due to an enlarged prostate gland
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- marked drowsiness may occur
- alcohol, sedatives and tranquilizers may increase drowsiness
- avoid alcoholic beverages
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Ask a doctor before use if you have
Ask your doctor or pharmacist before use if youaretaking sedatives or tranquilizers
When using this product
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 not more than 6 times in 24 hours
- adults and children 12 years and over: 1 or 2 tablets
- children 6 to under 12 years: 1 tablet
- children under 6 years: do not use
Other Information
- protect from moisture
- store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
- DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.
Inactive Ingredients
Colloidal silicon dioxide, Croscarmellose sodium, Dicalcium phosphate, Magnesium stearate, Microcrystalline cellulose, Phloxine B lake, Polyethylene glycol, Polyvinyl alcohol, Stearic acid, Talc, Titanium dioxide
Questions ?
call toll-free 1-844-912-4012
Package Label.Principal Display Panel
NDC55681-323-03
Compare to active ingredients of Benadryl ®Allergy Tablets*
ALLERGY RELIEF
DIPHENHYDRAMINE HCl
ANTIHISTAMINE
*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl ®Allergy ULTRATAB ®Tablets.
ITEM#PCOTC124
Distributed by:
Twin Med LLC
Santa Fe Springs, CA 90670
www.procureproducts.com
MADE IN THE U.S.A
* Please review the disclaimer below.
