Drug Facts
Active ingredient (in each caplet)
- Loratadine 10 mg
Dr Simi All Day Allergy Relief Tablet, Film Coated
FDA Label NDC 85786-201
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 All Day Allergy Relief (NDC 85786-201). 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, purpose, uses, warnings, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Purpose
- Antihistamine
Uses
Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- Runny Nose.
- Itchy, Watery Eyes.
- Sneezing.
- Itching of the nose or throat.
Warnings
Warnings
Do Not Use
if you have ever had an allergic reaction to this product or any of its ingredients.
Ask A Doctor Before Use If You Have
liver or kidney disease. Your doctor should determine if you need a different dose.
When Using This Product
do not take more than directed. Taking more than directed may cause drowsiness.
Stop Use And Ask A Doctor If
an allergic reaction to this product occurs. Seek medical help right away.
If Pregnant Or Breast-Feeding
ask a health professional before use.
Keep Out Of Reach Of Children
Keep out of reach of children
Overdosage
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
| Adults and children 6 years and over | 1 caplet daily; not more than 1 caplet in 24 hours |
| Children under 6 years of age | Ask a doctor |
| Consumers with liver or kidney disease | Ask a doctor |
Other Information
- Store between 20° to 25°C (68° to 77°F).
- Protect from exessive moisture.
- TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
Inactive Ingredients
Lactose monohydrate, Magnesium stearate, Pregelatinized starch (maize), Sodium starch glycolate.
Questions Or Comments?
(855)-280-1079
Other
Distributed by: FARMACIAS DE SIMILARES TX LLC
800 Brazos St Ste 260, Austin, TX, 78701, USA.
[email protected]
www.drsimi.com
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Package Label.Principal Display Panel
DR SIMI
NDC 85786-201-90
NON-DROWSY*
Allergy Relief
Loratadine 10 mg
Antihistamine
*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.
100 Caplets
24 Hour Allergy Relief
Original prescription strength
* Please review the disclaimer below.
