DailyMed - LEADER ALLERGY RELIEF D12- loratadine, pseudoephedrine sulfate tablet, film coated, extended release

NDC Code(s): 70000-0504-1, 70000-0504-2, 70000-0504-3
Packager: Cardinal Health 110, LLC. dba Leader

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

Drug Label Information

Updated June 17, 2021

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Active ingredients (in each tablet)
Loratadine 5 mg - Pseudoephedrine sulfate 120 mg

Loratadine 5 mg

Pseudoephedrine sulfate 120 mg
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Purpose
Antihistamine - Nasal decongestant

Antihistamine

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 - • temporarily relieves ...

•

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

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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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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 ...

Other information
• each tablet contains: calcium 25 mg - • do not use if blister unit is broken or torn - • store between 20° to 25°C (68° to 77°F) • keep in a dry place

•

each tablet contains: calcium 25 mg

•

do not use if blister unit is broken or torn

•

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

•

keep in a dry place

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Inactive ingredients
croscarmellose sodium, dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium stearate, pharmaceutical ink, povidone, titanium dioxide

croscarmellose sodium, dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium stearate, pharmaceutical ink, povidone, titanium dioxide
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Questions or comments?
1-800-719-9260

1-800-719-9260
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Package/Label Principal Display Panel
Non-Drowsy* | 12 Hour - Allergy Relief D-12 - Pseudoephedrine Sulfate, 120 mg | Loratadine, 5 mg - Extended-Release Tablets - Nasal Decongestant | Antihistamine - Allergy and Congestion - Indoor and Outdoor ...

Non-Drowsy* | 12 Hour

Allergy Relief D-12

Pseudoephedrine Sulfate, 120 mg | Loratadine, 5 mg

Extended-Release Tablets

Nasal Decongestant | Antihistamine

Allergy and Congestion

Indoor and Outdoor Allergies

Relief of: - Nasal and Sinus Congestion Due to Colds or Allergies

Sneezing – Runny Nose – Itchy, Watery Eyes

Itchy Throat or Nose Due to Allergies

COMPARE TO CLARITIN-D® 12 HOUR EXTENDED RELEASE TABLETS active ingredients

*When Taken as Directed. See Drug Facts Panel.

10 EXTENDED RELEASE TABLETS

Actual Size

100% Money Back Guarantee

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INGREDIENTS AND APPEARANCE

Product Information

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Published Date (What is this?)	Version	Files
Jun 18, 2021	3 (current)	download
Oct 13, 2020	2	download
Jan 15, 2020	1	download

	RxCUI	RxNorm NAME	RxTTY
1	1242399	pseudoephedrine sulfate 120 MG / loratadine 5 MG 12HR Extended Release Oral Tablet	PSN
2	1242399	12 HR loratadine 5 MG / pseudoephedrine sulfate 120 MG Extended Release Oral Tablet	SCD
3	1242399	loratadine 5 MG / pseudoephedrine sulfate 120 MG 12 HR Extended Release Oral Tablet	SY

Label: LEADER ALLERGY RELIEF D12- loratadine, pseudoephedrine sulfate tablet, film coated, extended release

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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

When using this product do not take more than directed.

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

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

	NDC
1	70000-0504-1
2	70000-0504-2
3	70000-0504-3

Label: LEADER ALLERGY RELIEF D12- loratadine, pseudoephedrine sulfate tablet, film coated, 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

When using this product do not take more than directed.

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

LEADER ALLERGY RELIEF D12- loratadine, pseudoephedrine sulfate tablet, film coated, extended release

Number of versions: 3

LEADER ALLERGY RELIEF D12- loratadine, pseudoephedrine sulfate tablet, film coated, extended release

LEADER ALLERGY RELIEF D12- loratadine, pseudoephedrine sulfate tablet, film coated, extended release

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LEADER ALLERGY RELIEF D12- loratadine, pseudoephedrine sulfate tablet, film coated, extended release

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