DR SIMI ALL DAY ALLERGY RELIEF- loratadine tablet, film coated

Dr Simi All Day Allergy Relief by

Drug Labeling and Warnings

Dr Simi All Day Allergy Relief by is a Otc medication manufactured, distributed, or labeled by Farmacias De Similares TX LLC, Granules India Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each caplet)

• Loratadine 10 mg

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

SPL UNCLASSIFIED SECTION

Distributed by: FARMACIAS DE SIMILARES TX LLC
800 Brazos St Ste 260, Austin, TX, 78701, USA.
customerservice@drsimi.com
www.drsimi.com

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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

INGREDIENTS AND APPEARANCE

DR SIMI ALL DAY ALLERGY RELIEF 
loratadine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85786-201
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
STARCH, CORN (UNII: O8232NY3SJ)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	G;10
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85786-201-90	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/15/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA210722	08/14/2025

Labeler - Farmacias De Similares TX LLC (119489934)

Establishment
Name	Address	ID/FEI	Business Operations
Granules India Limited		918609236	analysis(85786-201) , label(85786-201) , manufacture(85786-201) , pack(85786-201)