ALLERGY RELIEF 10 MG- loratadine tablet 
TWIN MED LLC

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TWIN MED - PROCURE - ALLERGY RELIEF (LORATADINE) TABLETS, 10 MG (55681-303)

Active ingredient (in each tablet)

Loratadine 10 mg

PURPOSE

ANTIHISTAMINE

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

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 over1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney diseaseask a doctor

Other information

Inactive ingredients

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

Questions?

call toll-free 1-800-935-6737

PDP

DF1

DF2

ALLERGY RELIEF  10 MG
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55681-303
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)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize7mm
FlavorImprint Code G;10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55681-303-03300 in 1 BOTTLE; Type 0: Not a Combination Product03/02/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21072203/02/2022
Labeler - TWIN MED LLC (009579330)

Revised: 3/2022
Document Id: d9d12a9b-223a-644f-e053-2995a90aade7
Set id: d943f548-aa0d-4476-e053-2a95a90a7bd4
Version: 2
Effective Time: 20220309
 
TWIN MED LLC