Claritin-D

Manufacturer: REMEDYREPACK INC.
Effective date: 2022-11-01
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-01 21:50:04

Label at a glance#

ProductClaritin-D 12 Hour

Active ingredientLORATADINE, PSEUDOEPHEDRINE SULFATE

Label structure9 sections

Indications and 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

Dosage and administration

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

Storage and handling

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

Contacts and useful links#

PhoneLabel contact1-800-252-7484

Websitewww.claritin.com

www.claritin.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

OTC - DO NOT USE SECTION

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.

OTC - ASK DOCTOR SECTION

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.

OTC - WHEN USING SECTION

When using this product do not take more than directed.

Taking more than directed may cause drowsiness.

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Remedy_Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-3566-0	2024-10-09	C162847	48780-1	1030e365-0995-111a-e063-dadaa90a10e2	Claritin-D ® 12 Hour
70518-3566-0	2024-01-30	C162847	48780-1	1030e365-0995-111a-e063-dadaa90a10e2	Claritin-D ® 12 Hour

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11523-7162-1	EA - Each	11523-7162	85cce7f3-cec5-4281-aaa0-08796678607d	1	2012-07-24
11523-7162-2	EA - Each	11523-7162	c215d904-7907-4d87-a34a-651e85e00f12	1	2012-07-24
11523-7162-3	EA - Each	11523-7162	a7d669e2-7d96-4d35-9050-886853111333	1	2012-07-24

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

Claritin-D 12 Hour
Loratadine and pseudoephedrine sulfate
CROSCARMELLOSE SODIUM
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE
TITANIUM DIOXIDE
LORATADINE
PSEUDOEPHEDRINE SULFATE
PSEUDOEPHEDRINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70518-3566	70518-3566-0
11523-7162

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	L11K75P92J	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POVIDONE	FZ989GH94E	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
LORATADINE	7AJO3BO7QN	ACTIB
PSEUDOEPHEDRINE SULFATE	Y9DL7QPE6B	ACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019670-002	CLARITIN-D	LORATADINE; PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2002-11-27

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019670-002	CLARITIN-D	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-11-27	`f41ea6bd6efb…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Claritin-D 12 Hour	LORATADINE AND PSEUDOEPHEDRINE SULFATE	Bayer HealthCare LLC.	a7125705-01ff-4418-8c53-9209c2bbb484	2025-12-05	Warnings	Exact identifier ndc (product): 11523-7162
240e6839-ae25-e5c5-e063-6394a90a2045			cb53b25e-a3a1-4fda-9528-1e48aae88487	2024-10-09	Warnings	Exact identifier spl set id: cb53b25e-a3a1-4fda-9528-1e48aae88487

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.