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

Leader Allergy Relief D12 by

Drug Labeling and Warnings

Leader Allergy Relief D12 by is a Otc medication manufactured, distributed, or labeled by Cardinal Health 110, LLC. dba Leader. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each tablet)

Loratadine 5 mg

Pseudoephedrine sulfate 120 mg

Purpose

Antihistamine

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 (1-800-222-1222).

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 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

Inactive ingredients

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

Questions or comments?

1-800-719-9260

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 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.

30 EXTENDED RELEASE TABLETS

Actual Size

100% Money Back Guarantee

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0504
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)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (to off-white)	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	7U0
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0504-3	30 in 1 CARTON	01/09/2020
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 70000-0504-2	20 in 1 CARTON	01/09/2020
2		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 70000-0504-1	10 in 1 CARTON	01/09/2020
3		1 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
ANDA	ANDA076050	01/09/2020

Labeler - Cardinal Health (097537435)