DailyMed - KIRKLAND SIGNATURE ALLERCLEAR D 24 HR EXTENDED RELEASE- loratadine and pseudoephedrine sulfate tablet, extended release

NDC Code(s): 63981-724-15
Packager: Kirkland-COSTCO WHOLESALE COMPANY

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 23, 2023

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SPL UNCLASSIFIED SECTION
Drug Facts

Drug Facts
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ACTIVE INGREDIENT
Active ingredients (in each tablet)Purpose - Loratadine, USP 10 mg - Antihistamine - Pseudoephedrine sulfate, USP 240 mg - Nasal decongestant

Active ingredients (in each tablet) Purpose

Loratadine, USP 10 mg

Antihistamine

Pseudoephedrine sulfate, USP 240 mg

Nasal decongestant

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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 - • reduces swelling of ...

•

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

•

reduces swelling of nasal passages

•

temporarily relieves sinus congestion and pressure

•

temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

•

temporarily restores freer breathing through the nose

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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 ...

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 (1-800-222-1222).

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Active ingredients (in each tablet)	Purpose
Loratadine, USP 10 mg	Antihistamine
Pseudoephedrine sulfate, USP 240 mg	Nasal decongestant

Directions

• do not divide, crush, chew or dissolve the tablet - adults and children 12 years and over - 1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours - children under ...

Other information
• sodium: contains 10 mg/tablet - • calcium: contains 25 mg/tablet - • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. • store between 20° C to 25° C ...

•

sodium: contains 10 mg/tablet

•

calcium: contains 25 mg/tablet

•

TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

•

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

•

protect from light and store in a dry place

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Inactive ingredients
calcium carbonate, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol ...

calcium carbonate, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, sodium alginate, sodium citrate, talc and titanium dioxide
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Questions?
call 1-800-406-7984

call 1-800-406-7984
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SPL UNCLASSIFIED SECTION
Manufactured by: Ohm Laboratories Inc. 1385 Livingston Avenue - North Brunswick, NJ 08902 - For Costco Wholesale Corporation - P.O. Box 34535 - Seattle, WA 98124-1535 ...

Manufactured by:
Ohm Laboratories Inc.
1385 Livingston Avenue
North Brunswick, NJ 08902
For Costco Wholesale Corporation
P.O. Box 34535
Seattle, WA 98124-1535 USA
1-800-774-2678
www.costco.com

**All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Claritin-D.®
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PRINCIPAL DISPLAY PANEL - 15 Tablet Blister Pack Carton
KIRKLAND - Signature™ COMPARE TO - CLARITIN-D® 24 HOUR - active ingredients** NDC 63981-724-15 - ITM. / ART. 1133953 - ALLERGY & CONGESTION - NON-DROWSY* ALLERCLEAR® D-24 hr - Pseudoephedrine Sulfate, USP 240 ...

KIRKLAND
Signature™

COMPARE TO
CLARITIN-D® 24 HOUR
active ingredients**

NDC 63981-724-15
ITM. / ART. 1133953

ALLERGY & CONGESTION
NON-DROWSY*

ALLERCLEAR® D-24 hr

Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant
Loratadine, USP 10 mg/Antihistamine
Extended-Release Tablets

Indoor & Outdoor Allergies

Actual Size

24 Hour Relief of:

• Nasal & Sinus Congestion due to Colds or Allergies
• Sneezing • Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose due to Allergies

*When taken as directed. See drug facts panel.

15
EXTENDED
RELEASE TABLETS

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INGREDIENTS AND APPEARANCE

Product Information

KIRKLAND SIGNATURE ALLERCLEAR D 24 HR EXTENDED RELEASE loratadine and pseudoephedrine sulfate tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63981-724
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
loratadine (UNII: 7AJO3BO7QN) (loratadine - UNII:7AJO3BO7QN)	loratadine	10 mg
pseudoephedrine sulfate (UNII: Y9DL7QPE6B) (pseudoephedrine - UNII:7CUC9DDI9F)	pseudoephedrine sulfate	240 mg

Ingredient Name	Strength
Inactive Ingredients
calcium carbonate (UNII: H0G9379FGK)
silicon dioxide (UNII: ETJ7Z6XBU4)
hydroxypropyl cellulose, unspecified (UNII: 9XZ8H6N6OH)
hypromellose, unspecified (UNII: 3NXW29V3WO)
ferrosoferric oxide (UNII: XM0M87F357)
lactose monohydrate (UNII: EWQ57Q8I5X)
magnesium stearate (UNII: 70097M6I30)
microcrystalline cellulose (UNII: OP1R32D61U)
polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)
povidone, unspecified (UNII: FZ989GH94E)
propylene glycol (UNII: 6DC9Q167V3)
sodium alginate (UNII: C269C4G2ZQ)
sodium citrate, unspecified form (UNII: 1Q73Q2JULR)
talc (UNII: 7SEV7J4R1U)
titanium dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	RX724
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63981-724-15	1 in 1 CARTON	08/25/2017
1		15 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076557	08/25/2017

Labeler - Kirkland-COSTCO WHOLESALE COMPANY (103391843)

Name	Address	ID/FEI	Business Operations
Establishment
Ohm Laboratories Inc.		184769029	MANUFACTURE(63981-724)

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Published Date (What is this?)	Version	Files
Aug 25, 2023	4 (current)	download
Apr 9, 2021	3	download
Jan 10, 2018	2	download
Oct 12, 2017	1	download

	RxCUI	RxNorm NAME	RxTTY
1	1117562	pseudoephedrine sulfate 240 MG / loratadine 10 MG 24HR Extended Release Oral Tablet	PSN
2	1117562	24 HR loratadine 10 MG / pseudoephedrine sulfate 240 MG Extended Release Oral Tablet	SCD
3	1117562	loratadine 10 MG / pseudoephedrine sulfate 240 MG 24 HR Extended Release Oral Tablet	SY
4	1369756	AllerClear D 10 MG / 240 MG 24HR Extended Release Oral Tablet	PSN
5	1369756	24 HR loratadine 10 MG / pseudoephedrine sulfate 240 MG Extended Release Oral Tablet [Allerclear]	SBD
6	1369756	AllerClear (loratadine 10 MG / pseudoephedrine sulfate 240 MG) 24 HR Extended Release Oral Tablet	SY

Label: KIRKLAND SIGNATURE ALLERCLEAR D 24 HR EXTENDED RELEASE- loratadine and pseudoephedrine sulfate tablet, extended release

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Drug Label Info

Safety

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More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

Find additional resources

Safety

Related Resources

More Info on this Drug

adults and children 12 years and over	1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours
children under 12 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Label: KIRKLAND SIGNATURE ALLERCLEAR D 24 HR EXTENDED RELEASE- loratadine and pseudoephedrine sulfate tablet, extended release

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

Find additional resources

Safety

Related Resources

More Info on this Drug

KIRKLAND SIGNATURE ALLERCLEAR D 24 HR EXTENDED RELEASE- loratadine and pseudoephedrine sulfate tablet, extended release

Number of versions: 4

KIRKLAND SIGNATURE ALLERCLEAR D 24 HR EXTENDED RELEASE- loratadine and pseudoephedrine sulfate tablet, extended release

KIRKLAND SIGNATURE ALLERCLEAR D 24 HR EXTENDED RELEASE- loratadine and pseudoephedrine sulfate tablet, extended release

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KIRKLAND SIGNATURE ALLERCLEAR D 24 HR EXTENDED RELEASE- loratadine and pseudoephedrine sulfate tablet, extended release

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.