Drug Facts Active Ingredient (In Each Tablet)
Diphenhydramine HCl 25 mg
Dr. Simi Allergy Relief Tablet
FDA Label NDC 85786-202
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Farmacias De Similares Tx Llc for the product Dr. Simi Allergy Relief (NDC 85786-202). 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 drug facts active ingredient (in each tablet), purpose, uses, warnings, 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, 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, common cold or other respiratory allergies:
■ sneezing ■ runny nose ■ itchy, watery eyes
■ itching of the nose or throat
■ Temporarily relieves these symptoms due to the common cold:
■ runny nose ■ sneezing
Warnings
.
Do Not Use
■ with any other product containing diphenhydramine, even one used on skin.
Ask A Doctor Before Use If You Have
■ glaucoma
■ trouble urinating due to an enlarged prostate gland
■ a breathing problem such as emphysema or chronic bronchitis.
Ask A Doctor Or Pharmacist Before Use If You Are
■ taking sedatives or tranquilizers.
When Using This Product
■ marked drowsiness may occur
■ avoid alcoholic drinks
■ alcohol, sedatives, and tranquilizers may increase drowsiness
■ be careful 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 right away (1-800-222-1222).
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 years and over | 1 to 2 tablets |
| Children 6 years to under 12 years | 1 tablet |
| Children under 6 years | Do not use |
Other Information
■ Each tablet contains: calcium 24 mg
■ Store at 20°–25°C (68°–77°F)
■ Avoid high humidity. Protect from moisture and light.
Inactive Ingredients
Colloidal Silicon Dioxide, Croscarmellose Sodium, Dicalcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose, Opadry II 85G54006 Pink.
Questions Or Comments?
(855)-280-1079
Principal Display Panel
NDC: 85786-202-24
DR. SIMI
Allergy Relief
Diphenhydramine HCl 25 mg
Relieves: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat
24 Tablets
Compare to the active ingredient in Benadryl® Allergy†
†This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl® Allergy.
Distributed in USA by:
FARMACIAS DE SIMILARES TX LLC
800 Brazos St Ste 260, Austin, TX, 78701, USA
[email protected]
www.drsimi.com
* Please review the disclaimer below.
