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 Health Pharma Usa 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 tablet)
Diphenhydramine HCl 25 mg
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
Warnings
Do not use
- with any other product containing diphenhydramine, even one used on skin
- to make a child sleepy
- trouble urinating due to an enlarged prostate gland
- glaucoma ? a breathing problem such as emphysema or chronic bronchitis
- marked drowsiness may occur
- avoid alcoholic drinks
- excitability may occur, especially in children ? alcohol, sedatives and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if youare taking 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 accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Do not exceed recommended dosage.
Directions
- take every 4 to 6 hours, not more than 6 doses in 24 hours
- Adults and children 12 years of age and older: 1 or 2 tablets
- children 6 to under 12 years of age: 1 tablet
- children 4 to under 6 years of age: do not use unless directed by a doctor
- children under 4 years of age: do not use
Other Information
- each tablet contains : calcium 20 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, Dicalcium Phosphate, D & C Red, Magnesium stearate, Microcrystalline cellulose, Titanium dioxide, Talc
Questions Or Comments
1-844-832-1138 (Mon-Fri 9AM-5PM EST) or www.healthlifeofusa.com
Package Label.Principal Display Panel
DIPHENHYDRAMINE HYDROCHLORIDE TABLET, USP 25 MG
ANTIHISTAMINE
* This product is not manufactured or distributed by McNeil-Consumer Healthcare, owner of the registered trademark Benadryl� Allergy.
71679-106-06 600 Caplets
71679-106-06 1000 Caplets
* Please review the disclaimer below.