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CLARITIN LIQUI-GELS- loratadine capsule, liquid filled Bayer HealthCare LLC. ---------- Claritin Liqui-Gels Drug Facts Active ingredient (in each capsule) 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. Directions adults and children 6 years and over 1 capsule daily; not more than 1 capsule in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor Other information safety sealed: do not use if the individual blister unit imprinted with Claritin® Liqui-Gels® is open or torn ® ®

Claritin ® Liqui-Gels...6 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 7 NDC:11523-7200-75 in 1 CARTON 06/16/2008 01/01/2016 7 9 in 1 BLISTER PACK; Type 0: Not a Combination

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Page 1: Claritin ® Liqui-Gels...6 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 7 NDC:11523-7200-75 in 1 CARTON 06/16/2008 01/01/2016 7 9 in 1 BLISTER PACK; Type 0: Not a Combination

CLARITIN LIQUI-GELS- loratadine capsule, liquid filled Bayer HealthCare LLC.----------

Claritin

Liqui-Gels Drug Facts

Active ingredient (in each capsule)Loratadine 10 mg

PurposeAntihistamine

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

runny noseitchy, watery eyessneezingitching of the nose or throat

WarningsDo 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 youneed a different dose.

When us ing this product do not take more than directed. Taking more than directed may causedrowsiness.

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breas t-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison ControlCenter right away.

Directions

adults and children 6 years andover

1 capsule daily; not more than 1 capsule in 24hours

children under 6 years of age ask a doctorconsumers with liver or kidneydisease ask a doctor

Other informationsafety sealed: do not use if the individual blister unit imprinted with Claritin® Liqui-Gels® is openor torn

®

®

Page 2: Claritin ® Liqui-Gels...6 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 7 NDC:11523-7200-75 in 1 CARTON 06/16/2008 01/01/2016 7 9 in 1 BLISTER PACK; Type 0: Not a Combination

store between 20° to 25°C (68° to 77°F)protect from freezing

Inactive ingredientscaprylic/capric glycerides, FD&C blue no.1, gelatin, glycerin, pharmaceutical ink, polysorbate 80,povidone, purified water, sorbitol

Questions or comments?1-800-CLARITIN (1-800-252-7484) or www.claritin.com© Copyright & Distributed by MSD Consumer Care, Inc., PO Box 377, Memphis, TN 38151 USA, a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ USA.

PRINCIPAL DISPLAY PANEL - 10 Capsule CartonNon-Drowsy*

Claritin

Liqui-Gels

24

Hour

Relief of:SneezingRunny NoseItchy, Watery EyesItchy Throat or Nose

loratadine 10 mg/antihistamine

Indoor & Outdoor

Allergies*When taken as directed.

See Drug Facts Panel.

10 LIQUID-FILLED

CAPSULES

®

®

Page 3: Claritin ® Liqui-Gels...6 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 7 NDC:11523-7200-75 in 1 CARTON 06/16/2008 01/01/2016 7 9 in 1 BLISTER PACK; Type 0: Not a Combination
Page 4: Claritin ® Liqui-Gels...6 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 7 NDC:11523-7200-75 in 1 CARTON 06/16/2008 01/01/2016 7 9 in 1 BLISTER PACK; Type 0: Not a Combination

CLARITIN LIQUI-GELS loratadine capsule, liquid filled

Product Information

Page 5: Claritin ® Liqui-Gels...6 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 7 NDC:11523-7200-75 in 1 CARTON 06/16/2008 01/01/2016 7 9 in 1 BLISTER PACK; Type 0: Not a Combination

Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:11523-720 0

Route of Adminis tration ORAL

Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength

LO RATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE 10 mg

Inactive IngredientsIngredient Name Strength

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

GELATIN (UNII: 2G8 6 QN327L)

GLYCERIN (UNII: PDC6 A3C0 OX)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

WATER (UNII: 0 59 QF0 KO0 R)

SO RBITO L (UNII: 50 6 T6 0 A25R)

Product CharacteristicsColor blue (Clear Blue) Score no sco re

Shape CAPSULE Siz e 10 mm

Flavor Imprint Code C;10

Contains

Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NDC:11523-720 0 -1 1 in 1 CARTON 0 6 /16 /20 0 8

1 10 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

2 NDC:11523-720 0 -2 3 in 1 CARTON 0 6 /16 /20 0 8 0 1/0 1/20 16

2 8 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

3 NDC:11523-720 0 -3 4 in 1 CARTON 0 6 /16 /20 0 8 0 1/0 1/20 16

3 10 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

4 NDC:11523-720 0 -5 1 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct 0 6 /16 /20 0 8 0 1/0 1/20 16

5 NDC:11523-720 0 -4 7 in 1 CARTON 0 6 /16 /20 0 8 0 1/0 1/20 16

5 10 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

6 NDC:11523-720 0 -6 3 in 1 CARTON 0 6 /16 /20 0 8

6 10 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

7 NDC:11523-720 0 -7 5 in 1 CARTON 0 6 /16 /20 0 8 0 1/0 1/20 16

7 9 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

8 NDC:11523-720 0 -8 4 in 1 CARTON 0 6 /16 /20 0 8

8 10 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

9 NDC:11523-720 0 -9 6 in 1 CARTON 0 6 /16 /20 0 8

9 10 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Page 6: Claritin ® Liqui-Gels...6 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 7 NDC:11523-7200-75 in 1 CARTON 06/16/2008 01/01/2016 7 9 in 1 BLISTER PACK; Type 0: Not a Combination

Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date

NDA NDA0 219 52 0 6 /16 /20 0 8

CLARITIN LIQUI-GELS loratadine capsule, liquid filled

Product InformationProduct T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:11523-7333

Route of Adminis tration ORAL

Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength

LO RATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE 10 mg

Inactive IngredientsIngredient Name Strength

GLYCERIN (UNII: PDC6 A3C0 OX)

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

WATER (UNII: 0 59 QF0 KO0 R)

SO RBITO L (UNII: 50 6 T6 0 A25R)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

GELATIN (UNII: 2G8 6 QN327L)

Product CharacteristicsColor blue (Clear Blue) Score no sco re

Shape CAPSULE Siz e 10 mm

Flavor Imprint Code C;10

Contains

Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NDC:11523-7333-1 1 in 1 CARTON 0 6 /16 /20 0 8

1 5 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

2 NDC:11523-7333-3 4 in 1 CARTON 0 6 /16 /20 0 8

2 9 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

3 NDC:11523-7333-4 7 in 1 CARTON 0 6 /16 /20 0 8

3 10 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Page 7: Claritin ® Liqui-Gels...6 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 7 NDC:11523-7200-75 in 1 CARTON 06/16/2008 01/01/2016 7 9 in 1 BLISTER PACK; Type 0: Not a Combination

Bayer HealthCare LLC.

Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date

NDA NDA0 219 52 0 6 /16 /20 0 8

Labeler - Bayer HealthCare LLC. (112117283)

Revised: 12/2019