Active Ingredient (In Each Tablet)
Diphenhydramine HCl 25 mg
Allergy Relief Tablet
FDA Label NDC 80513-722
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Advanced Rx Llc for the product Allergy Relief (NDC 80513-722). 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 your doctor or pharmacist before use if you are, when using this product, otc - pregnancy 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
- sneezing
- itchy, watery eyes
- itchy nose or throat
- temporarily relieves these symptoms of the common cold:
- runny nose
- sneezing
Do Not Use
- with any other product containing diphenhydramine, even one used on skin
- to make a child sleepy
Ask A Doctor Before Use If You Have
- trouble urinating due to an enlarged prostate gland
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
Ask Your Doctor Or Pharmacist Before Use If You Are
- taking sedatives or tranquilizers.
When Using This Product
- marked drowsiness may occur
- avoid alcoholic beverages
- excitability may occur, especially in children
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Otc - Pregnancy Or Breast Feeding
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.
Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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:1 or 2 caplets
Children 6 to under 12 years of age:1 caplet
Children under 6 years of age: do not use
Other Information
- Each caplet contains:Calcium 23.52 mg
- store at controlled room temperature 20°-25°C (68°-77°F)
- read all product information before using.
- TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
Inactive Ingredients
Colloidal Silicon Dioxide, Croscarmellose Sodium, D&C Red #27, Dicalcium Phosphate, Lecithin, Magnesium Stearate, Microcrystalline Cellulose, Polyvinyl alcohol, Titanium dioxide, Talc
Questions Or Comments?
Call toll free 1-800-630-8895
Monday through Friday 9 AM - 5 PM EST.
Other
Distributed by:
Advanced Rx LLC
1942 NE 163rd St North Miami Beach,
FL 33162 U.S.A.
MADE IN THE USA
Package Label.Principal Display Panel
NDC 80513-722-06
Compare to Benadryl ®Allergy Ultratab ®active ingredient*
ALLERGY RELIEF
DIPHENHYDRAMINE HCl 25 mg
ANTIHISTAMINE
RELIEVES:
Sneezing
Itchy, Watery Eyes
Runny Nose
Itchy Throat
600
MINI TABLETS
*This product is not manufactured or distributed by McNeil-Consumer Healthcare, owner of the registered trademark Benadryl ®Allergy Ultratab ®
Label (Label)
* Please review the disclaimer below.
