OTC Medication Information: Loratadine Allergy Relief

LORATADINE ALLERGY RELIEF- loratadine tablet
WinCo Foods, LLC

ACTIVE INGREDIENT(S)

Loratadine, USP 10 mg

PURPOSE

Antihistamine

USE(S)

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 and kidney disease

ask a doctor

OTHER INFORMATION

store between 20° to 25° C (68° to 77° F)
protect from excessive moisture
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW AN SIGN OF TAMPERING.

INACTIVE INGREDIENTS

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

QUESTIONS?

or to report an adverse event call 800-824-7984 Monday — Friday 9am — 4pm MST

PRINCIPAL DISPLAY PANEL — 10 Tablet Blister Pack Carton

*Compare to the active ingredient in CLARITIN®
†When taken as directed. See Drug Facts Panel.

WinCo™
FOODS

24 HOUR
NON-DROWSY

Allergy Relief

Indoor & Outdoor Allergies

LORATADINE TABLETS,
USP 10 mg/ANTIHISTAMINE

Original
Prescription Strength

Relief of: Sneezing,
Runny Nose,
Itchy, Watery Eyes &
Itchy Throat or Nose

10Tablets

PRINCIPAL DISPLAY PANEL -- 10 Tablet Blister Pack Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 30 Tablet Blister Pack Carton

*Compare to the active ingredient in CLARITIN®
†When taken as directed. See Drug Facts Panel.

WinCo™
FOODS

24 HOUR
NON-DROWSY

Allergy Relief

Indoor & Outdoor Allergies

LORATADINE TABLETS,
USP 10 mg/ANTIHISTAMINE

Original
Prescription Strength

Relief of: Sneezing,
Runny Nose,
Itchy, Watery Eyes &
Itchy Throat or Nose

30Tablets

PRINCIPAL DISPLAY PANEL -- 30 Tablet Blister Pack Carton
(click image for full-size original)
LORATADINE ALLERGY RELIEF loratadine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67091-245
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
STARCH, CORN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
Product Characteristics
Color white (White to Off White) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code RX526
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67091-245-10 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (67091-245-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076134 08/28/2003
LORATADINE ALLERGY RELIEF loratadine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67091-246
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
STARCH, CORN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
Product Characteristics
Color white (White to Off White) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code RX526
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67091-246-30 30 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (67091-246-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076134 08/28/2003
Labeler — WinCo Foods, LLC (056098817)
Registrant — Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
Name Address ID/FEI Operations
Ohm Laboratories Inc. 051565745 MANUFACTURE (67091-245), MANUFACTURE (67091-246)

Revised: 08/2018 WinCo Foods, 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.

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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