Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID cdecad62-bf1e-43fb-b4be-8fc54b63e4ae
Route
ORAL
Published
Effective Date 2019-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loratadine (10 mg) Pseudoephedrine (240 mg)
Inactive Ingredients
Silicon Dioxide Hydroxypropyl Cellulose (1600000 Wamw) Calcium Carbonate 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

Identifiers & Packaging

Pill Appearance
Imprint: RC17 Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2017-06-06

Description

Loratadine, USP 10 mg Pseudoephedrine sulfate, USP 240 mg

Purpose

Antihistamine Nasal decongestant


Medication Information

Purpose

Antihistamine

Nasal decongestant

Description

Loratadine, USP 10 mg Pseudoephedrine sulfate, USP 240 mg

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
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

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.
Questions?

call 1-800-406-7984

Keep the carton. It contains important information.

See end panel for expiration date.

Distributed by McKesson

One Post Street, San Francisco, CA 94104

www.healthmart.com/healthmartbrand

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. (for blister cartons only)
  • store between 20° C to 25° C (68° F to 77° F).
  • protect from light and store in a dry place
Active Ingredients

Loratadine, USP 10 mg

Pseudoephedrine sulfate, USP 240 mg

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

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).

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.

Principal Display Panel 10 Mg/240 Mg Tablet Blister Pack Carton

NDC 62011-0071-2

Health Mart ®

Compare to Claritin-D ®24 Hour

active ingredients

ORIGINAL PRESCRIPTION STRENGTH • NON-DROWSY*

Allergy Relief &

Nasal Decongestant

Loratadine, USP 10 mg/Antihistamine

Pseudoephedrine Sulfate,

USP 240 mg/Nasal Decongestant

Indoor & Outdoor Allergies

24 Hour Relief Of: Nasal & Sinus Congestion Due to Colds

or Allergies Sneezing/Runny Nose/Itchy, Watery Eyes/

Itchy Throat or Nose Due to Allergies

ACTUAL SIZE

15 Extended-Release Tablets

*When Taken as Directed. See Drug Facts Panel.


Structured Label Content

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
Purpose

Antihistamine

Nasal decongestant

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

Do Not Use (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.
Questions?

call 1-800-406-7984

Keep the carton. It contains important information.

See end panel for expiration date.

Distributed by McKesson

One Post Street, San Francisco, CA 94104

www.healthmart.com/healthmartbrand

Other Information (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. (for blister cartons only)
  • store between 20° C to 25° C (68° F to 77° F).
  • protect from light and store in a dry place
Active Ingredients (Active ingredients)

Loratadine, USP 10 mg

Pseudoephedrine sulfate, USP 240 mg

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

Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use

Keep Out of Reach of Children. (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).

Ask A Doctor Before Use If You Have (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. (When using this product do not take more than directed.)

Taking more than directed may cause drowsiness.

Principal Display Panel 10 Mg/240 Mg Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 10 mg/240 mg Tablet Blister Pack Carton)

NDC 62011-0071-2

Health Mart ®

Compare to Claritin-D ®24 Hour

active ingredients

ORIGINAL PRESCRIPTION STRENGTH • NON-DROWSY*

Allergy Relief &

Nasal Decongestant

Loratadine, USP 10 mg/Antihistamine

Pseudoephedrine Sulfate,

USP 240 mg/Nasal Decongestant

Indoor & Outdoor Allergies

24 Hour Relief Of: Nasal & Sinus Congestion Due to Colds

or Allergies Sneezing/Runny Nose/Itchy, Watery Eyes/

Itchy Throat or Nose Due to Allergies

ACTUAL SIZE

15 Extended-Release Tablets

*When Taken as Directed. See Drug Facts Panel.


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