12 HOUR ALLERGY AND CONGESTION- loratadine, pseudoephedrine sulfate tablet, film coated, extended release

12 hour allergy and congestion by

Drug Labeling and Warnings

12 hour allergy and congestion by is a Otc medication manufactured, distributed, or labeled by Walgreen Company. 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*

Wal-itin® D

Compare to Claritin-D® 12 Hour Tablets active ingredients

12 HOUR ALLERGY & CONGESTION

PSEUDOEPHEDRINE SULFATE 120 mg / NASAL DECONGESTANT

LORATADINE 5 mg / ANTIHISTAMINE

EXTENDED-RELEASE TABLETS

12 HOUR - EXTENDED RELEASE TABLETS

INDOOR & OUTDOOR ALLERGIES

12-hour relief of: nasal & sinus congestion due to colds or allergies; sneezing; runny nose; itchy, watery eyes & itchy throat or nose due to allergies

30 EXTENDED-RELEASE TABLETS

*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.

12 HOUR

ACTUAL SIZE

INGREDIENTS AND APPEARANCE

12 HOUR ALLERGY AND CONGESTION 
loratadine, pseudoephedrine sulfate tablet, film coated, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-1133
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)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE (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: 0363-1133-46	10 in 1 CARTON	05/05/2018
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0363-1133-60	20 in 1 CARTON	05/05/2018
2		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 0363-1133-65	30 in 1 CARTON	05/05/2018
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	05/05/2018

Labeler - Walgreen Company (008965063)