OTC Medication Information: Loratadine

LORATADINE — loratadine tablet
Aurohealth LLC

Drug Facts

Active ingredient (in each tablet)

Loratadine USP 10 mg

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

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.

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 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor

Other information


  • Tamper-evident: do not use if foil seal under cap, printed with “SEALED for YOUR PROTECTION” is missing, open or broken
  • store at 20° to 25°C (68° to 77°F)
  • protect from excessive moisture

Inactive ingredients

lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate.

Questions or comments?


call 1-855-274-4122

Distributed by: AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648
Made in India
Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 10 mg (45 Tablets Bottle)

NDC 58602-702-17
Non-Drowsy*
Loratadine
Tablets USP 10 mg
Antihistamine

24 Hour
Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

Indoor & Outdoor
Allergies
*When taken as directed.
See Drug Facts Panel. 45 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 10 mg (45 Tablets Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 10 mg Container Carton (45 Tablets)

NDC 58602-702-17
# Compare to the active
ingredient in claritin®

Non-Drowsy*
Loratadine
Tablets USP 10 mg
Antihistamine
Indoor & Outdoor Allergies

24 Hour
Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

*When taken as directed
See Drug Facts Panel. 45 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 10 mg Container Carton (45 Tablets)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 10 mg Blister Carton (30 Tablets)

NDC 58602-702-84
# Compare to the active
ingredient in claritin®
Non-Drowsy*
Loratadine
Tablets USP 10 mg
Antihistamine
Indoor & Outdoor Allergies

24 Hour
Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

*When taken as directed.
See Drug Facts Panel.
30 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 10 mg Blister Carton (30 Tablets)
(click image for full-size original)

LORATADINE loratadine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-702
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LORATADINE (LORATADINE) LORATADINE 10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE (White to Off-white) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 39;L
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58602-702-17 1 BOTTLE in 1 CARTON contains a BOTTLE
1 45 TABLET in 1 BOTTLE This package is contained within the CARTON (58602-702-17)
2 NDC:58602-702-15 1 BOTTLE in 1 CARTON contains a BOTTLE
2 60 TABLET in 1 BOTTLE This package is contained within the CARTON (58602-702-15)
3 NDC:58602-702-19 1 BOTTLE in 1 CARTON contains a BOTTLE
3 90 TABLET in 1 BOTTLE This package is contained within the CARTON (58602-702-19)
4 NDC:58602-702-81 1 BOTTLE in 1 CARTON contains a BOTTLE
4 108 TABLET in 1 BOTTLE This package is contained within the CARTON (58602-702-81)
5 NDC:58602-702-32 1 BOTTLE in 1 CARTON contains a BOTTLE
5 180 TABLET in 1 BOTTLE This package is contained within the CARTON (58602-702-32)
6 NDC:58602-702-60 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
6 5 TABLET in 1 BLISTER PACK This package is contained within the CARTON (58602-702-60)
7 NDC:58602-702-83 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
7 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (58602-702-83)
8 NDC:58602-702-67 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
8 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (58602-702-67)
9 NDC:58602-702-84 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
9 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (58602-702-84)
10 NDC:58602-702-05 5 BLISTER PACK in 1 CARTON contains a BLISTER PACK
10 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (58602-702-05)
11 NDC:58602-702-09 1 BOTTLE in 1 CARTON contains a BOTTLE
11 30 TABLET in 1 BOTTLE This package is contained within the CARTON (58602-702-09)
12 NDC:58602-702-38 1 BOTTLE in 1 CARTON contains a BOTTLE
12 300 TABLET in 1 BOTTLE This package is contained within the CARTON (58602-702-38)
13 NDC:58602-702-39 1 BOTTLE in 1 CARTON contains a BOTTLE
13 365 TABLET in 1 BOTTLE This package is contained within the CARTON (58602-702-39)
14 NDC:58602-702-44 1 BOTTLE in 1 CARTON contains a BOTTLE
14 400 TABLET in 1 BOTTLE This package is contained within the CARTON (58602-702-44)
15 NDC:58602-702-54 1 BOTTLE in 1 CARTON contains a BOTTLE
15 70 TABLET in 1 BOTTLE This package is contained within the CARTON (58602-702-54)
16 NDC:58602-702-23 1 BOTTLE in 1 CARTON contains a BOTTLE
16 120 TABLET in 1 BOTTLE This package is contained within the CARTON (58602-702-23)
17 NDC:58602-702-40 1 BOTTLE in 1 CARTON contains a BOTTLE
17 500 TABLET in 1 BOTTLE This package is contained within the CARTON (58602-702-40)
18 NDC:58602-702-21 1 BOTTLE in 1 CARTON contains a BOTTLE
18 100 TABLET in 1 BOTTLE This package is contained within the CARTON (58602-702-21)
19 NDC:58602-702-04 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
19 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (58602-702-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208314 04/16/2018
Labeler — Aurohealth LLC (078728447)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650381903 ANALYSIS (58602-702), MANUFACTURE (58602-702)

Revised: 02/2020 Aurohealth LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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