Topco Associates LLC. Clear Time™ Drug Facts

topcare clear time by

Drug Labeling and Warnings

topcare clear time by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TOPCARE CLEAR TIME- loratadine tablet 
Topco Associates LLC

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Topco Associates LLC. Clear Time™ Drug Facts

Active ingredient (in each tablet)

Loratadine 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 right away. (1-800-222-1222)

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

  • do not use if blister unit is broken or torn
  • store between 20°-25°C (68°-77°F)
  • protect from excessive moisture

Inactive ingredients

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Questions or comments?

1-888-423-0139

Package/Label Principal Display Panel

ORIGINAL PRESCRIPTION STRENGTH

Clear Time™

LORATADINE TABLETS, 10 mg

ANTIHISTAMINE

Indoor and Outdoor Allergies

24 Hour

Relief of:

Sneezing

Runny nose

Itchy, watery eyes

Itchy throat or nose

COMPARE TO QLEARQUIL™ 24 HOUR ALLERGY RELIEF active ingredient

actual size

30 TABLETS

Non-Drowsy*

*When taken as directed.

See Drug Facts Panel.

Topcare Clear Time Image 1.jpg

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TOPCARE CLEAR TIME 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 36800-929
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE (UNII: FZ989GH94E)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize8mm
FlavorImprint Code L612
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 36800-929-3930 in 1 CARTON01/13/201506/16/2016
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC: 36800-929-4610 in 1 CARTON01/22/201502/10/2018
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07630101/13/201502/10/2018
Labeler - Topco Associates LLC (006935977)

Revised: 12/2019
Document Id: 944725d2-f66d-4826-a56b-218d277e1e1b
Set id: b0ec1b05-875d-4a62-84f5-091ee89a241e
Version: 3
Effective Time: 20191216
 
Topco Associates LLC