Claritin-D ® 12 Hour

Claritin-D by

Drug Labeling and Warnings

Claritin-D by is a Otc medication manufactured, distributed, or labeled by REMEDYREPACK INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CLARITIN-D 12 HOUR- loratadine and pseudoephedrine sulfate tablet, extended release 
REMEDYREPACK INC.

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Claritin-D ®



12 Hour

Drug Facts

Active ingredient (in each tablet)	Purpose
Loratadine 5 mg	Antihistamine
Pseudoephedrine sulfate 120 mg	Nasal decongestant

Uses

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • sneezing
  • itchy, watery eyes
  • runny nose
  • itching of the nose or throat
• temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
• reduces swelling of nasal passages
• temporarily relieves sinus congestion and pressure
• temporarily restores freer breathing through the nose

Warnings

Do not use

• if you have ever had an allergic reaction to this product or any of its ingredients
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• heart disease
• thyroid disease
• high blood pressure
• diabetes
• trouble urinating due to an enlarged prostate gland
• 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.
• symptoms do not improve within 7 days or are accompanied by a fever
• nervousness, dizziness or sleeplessness occurs

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

• do not divide, crush, chew or dissolve the tablet

• adults and children 12 years and over: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
• children under 12 years of age: ask a doctor
• consumers with liver or kidney disease: ask a doctor

Other information

• each tablet contains: calcium 30 mg
• safety sealed: do not use if the individual blister unit imprinted with Claritin-D ® 12 Hour is open or torn
• store between 20° to 25°C (68° to 77°F)
• keep in a dry place

Inactive ingredients

croscarmellose sodium, dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium sterarate, pharmaceutical ink, povidone, titanium dioxide

Questions or comments?

1-800-CLARITIN (1-800-252-7484) or www.claritin.com

DRUG: Claritin-D12 Hour 12 Hour

GENERIC: Loratadine and pseudoephedrine sulfate

DOSAGE: TABLET, EXTENDED RELEASE

ADMINSTRATION: ORAL

NDC: 70518-3566-0

COLOR: white

SHAPE: OVAL

SCORE: No score

SIZE: 12 mm

IMPRINT: Claritin;D;12

PACKAGING: 10 in 1 BLISTER PACK

OUTER PACKAGING: 2 in 1 CARTON

ACTIVE INGREDIENT(S):

• PSEUDOEPHEDRINE SULFATE 120mg in 1
• LORATADINE 5mg in 1

INACTIVE INGREDIENT(S):

• CROSCARMELLOSE SODIUM
• CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
• HYPROMELLOSES
• LACTOSE MONOHYDRATE
• MAGNESIUM STEARATE
• POVIDONE
• TITANIUM DIOXIDE

CLARITIN-D  12 HOUR
loratadine and pseudoephedrine sulfate tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70518-3566(NDC: 11523-7162)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	5 mg
PSEUDOEPHEDRINE SULFATE (UNII: Y9DL7QPE6B) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE SULFATE	120 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE (UNII: FZ989GH94E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white (white to off-white)	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	Claritin;D;12
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70518-3566-0	2 in 1 CARTON	10/31/2022	11/03/2023
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019670	10/31/2022	11/03/2023

Labeler - REMEDYREPACK INC. (829572556)

Revised: 10/2024

Document Id: 240e6839-ae25-e5c5-e063-6394a90a2045

34390-5

Set id: cb53b25e-a3a1-4fda-9528-1e48aae88487

Version: 2

Effective Time: 20241009