Loratadine and Pseudoephedrine Sulfate: Package Insert and Label Information

LORATADINE AND PSEUDOEPHEDRINE SULFATE- loratadine and pseudoephedrine sulfate tablet, film coated, extended release
Amerisource Bergen

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 over1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours
    children under 12 years of ageask a doctor
    consumers with liver or kidney diseaseask 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 — 10 Tablet Blister Pack Carton

Compare to active ingredients in
Claritin-D® 24 hour**

GOOD
NEIGHBOR
PHARMACY®

NDC 46122-167-52

Non-Drowsy*

24 HOUR

Allergy &
Congestion Relief
pseudoephedrine sulfate, USP 240 mg/nasal decongestant
loratadine, USP 10 mg/antihistamine

Indoor & Outdoor Allergies

Extended-Release Tablets

Relief of: • Nasal and Sinus Congestion Due to Colds or Allergies
• Sneezing • Runny Nose • Itchy, Watery Eyes
• Itchy Throat or Nose Due to Allergies

10 extended-release tablets

*When taken as directed. See Drug Facts Panel.

Principal Display Panel -- 10 Tablet Blister Pack Carton
(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:46122-167
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 (1600000 WAMW)
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:46122-167-52 10 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 — Amerisource Bergen (007914906)
Establishment
Name Address ID/FEI Operations
Ohm Laboratories Inc. 051565745 manufacture (46122-167)

Revised: 06/2021 Amerisource Bergen

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