Loratadine: Package Insert and Label Information

LORATADINE- loratadine tablet
DRUG OCEAN LLC

Active ingredient

Loratadine 10 mg

Purpose

Antihistamine

Uses

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

  • runny nose
  • sneezing
  • itchy, water eyes
  • 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 usung 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.

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 under cap is missing, open or broken
  • store between 20º to 25ºC (68º to 77ºF)

Inactive ingredients

Lactose monohydrate, magnesium stearate, povidone, starch maize pregelatinized

Questions or comments?

1-844-200-6566 Monday to Friday 9 AM to 5 PM EST

DISPLAY PANEL

Compare to the active ingredient in Claritin®†

NON-DROWSY*

Original Prescription Strength

Loratadine Tablets, 10 mg / Antihistamine

Indoor & Outdoor Allergies

24 Hour Relief of: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose

365 Tablets

*When taken as directed

See Drug Facts Panel

†This product is not manufactured or distributed by Bayer Healthcare, LLC, owner of the registered trademark Claritin®.

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LORATADINE
loratadine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70985-017
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
STARCH, CORN
POVIDONE
MAGNESIUM STEARATE
Product Characteristics
Color white (White to off white) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code P;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70985-017-01 100 TABLET in 1 PACKAGE None
2 NDC:70985-017-10 10 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214684 06/27/2021
Labeler — DRUG OCEAN LLC (080381835)
Registrant — DRUG OCEAN LLC (080381835)
Establishment
Name Address ID/FEI Operations
Unique Pharmaceutical Laboratories 650434645 manufacture (70985-017)

Revised: 06/2021 DRUG OCEAN LLC

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