Loratadine and Pseudoephedrine Sulfate: Package Insert and Label Information

LORATADINE AND PSEUDOEPHEDRINE SULFATE- loratadine and pseudoephedrine sulfate tablet, film coated, extended release
Meijer Distribution, Inc.

ACTIVE INGREDIENTS (IN EACH TABLET)

Loratadine, USP 10 mg

Pseudoephedrine sulfate, USP 240 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
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

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 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

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 (68° F to 77° F).
protect from light and store in a dry place

INACTIVE INGREDIENTS

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

QUESTIONS?

Call 1-800-406-7984

PRINCIPAL DISPLAY PANEL

NDC 41250-724-69

Compare to CLARITIN-D ® 24 HOUR active ingredients **

meijer

Original Prescription Strength

Non-Drowsy *

24 HOUR

Allergy Relief & Nasal Decongestant

Loratadine, USP 10 mg · Antihistamine

Pseudoephedrine Sulfate, USP 240 mg · Nasal Decongestant

Indoor & Outdoor Allergies

Relief of:

sneezing; runny nose; itchy, watery eyes;

itchy throat or nose due to allergies

nasal & sinus congestion due to colds or allergies

* When taken as directed.

See Drug Facts Panel.

10 EXTENDED-RELEASE TABLETS

DIST. BY MEIJER DISTRIBUTION, INC.

5079439/R0710

This is the 10 count blister carton label for Meijer Loratadine D tablets.
(click image for full-size original)
LORATADINE AND PSEUDOEPHEDRINE SULFATE
loratadine and pseudoephedrine sulfate tablet, film coated, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-724
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LORATADINE (LORATADINE) LORATADINE 10 mg
PSEUDOEPHEDRINE SULFATE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE SULFATE 240 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE
SILICON DIOXIDE
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
FERROSOFERRIC OXIDE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
STARCH, CORN
PROPYLENE GLYCOL
SHELLAC
SODIUM ALGINATE
SODIUM CITRATE, UNSPECIFIED FORM
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white (White to Off-white) Score no score
Shape CAPSULE Size 17mm
Flavor Imprint Code RX724
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41250-724-69 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK None
2 NDC:41250-724-52 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076557 11/17/2004
Labeler — Meijer Distribution, Inc. (006959555)
Establishment
Name Address ID/FEI Operations
Ohm Laboratories Inc. 051565745 MANUFACTURE (41250-724)

Revised: 03/2021 Meijer Distribution, Inc.

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