Allergy Relief & Nasal Decongestant

Drug Facts

Composition & Product

Active Ingredients

Loratadine (10 mg) Pseudoephedrine (240 mg)

Inactive Ingredients

Calcium Carbonate Silicon Dioxide Hydroxypropyl Cellulose (1600000 Wamw) Hypromellose, Unspecified Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose Povidone, Unspecified Starch, Corn Propylene Glycol Shellac Sodium Alginate Sodium Citrate, Unspecified Form Talc Titanium Dioxide Ferrosoferric Oxide Polyethylene Glycol, Unspecified

Identifiers & Packaging

Pill Appearance

Imprint: RX724 Shape: oval Color: white Size: 17 mm Score: 1

Marketing Status

ANDA Active Since 2004-11-17

Medication Information

Description

Drug Facts

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

Section 42229-5

Drug Facts

Section 50565-1

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).

Section 50567-7

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Active ingredients (in each tablet)	Purpose
Loratadine, USP 10 mg	Antihistamine
Pseudoephedrine sulfate, USP 240 mg	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

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

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

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

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.

Principal Display Panel 10 Tablet Blister Pack Carton

NDC 11822-9990-0

24 HOUR

Compare to the active ingredients in

Claritin-D^® 24 Hour**

ORIGINAL PRESCRIPTION STRENGTH

ALLERGY RELIEF &

NASAL DECONGESTANT

LORATADINE, USP 10 mg / PSEUDOEPHEDRINE SULFATE, USP 240 mg

ANTIHISTAMINE & NASAL DECONGESTANT

NON-DROWSY*

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

*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.

ACTUAL SIZE

10

EXTENDED-

RELEASE TABLETS

Principal Display Panel 15 Tablet Blister Pack Carton

24 HOUR

Compare to the active ingredients of Claritin-D^® 24 Hour**

NDC 11822-9990-5

ORIGINAL PRESCRIPTION STRENGTH

ALLERGY RELIEF &

NASAL DECONGESTANT

LORATADINE, USP 10 mg / PSEUDOEPHEDRINE SULFATE, USP 240 mg

ANTIHISTAMINE & NASAL DECONGESTANT

NON-DROWSY*

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

*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.

ACTUAL SIZE

15

EXTENDED-

RELEASE TABLETS

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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).

Section 50567-7 (50567-7)

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Active ingredients (in each tablet)	Purpose
Loratadine, USP 10 mg	Antihistamine
Pseudoephedrine sulfate, USP 240 mg	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

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.
store between 20° C to 25° C (68° F to 77° F).
protect from light and store in a dry place

Inactive Ingredients (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

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.

Principal Display Panel 10 Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 10 Tablet Blister Pack Carton)

NDC 11822-9990-0

24 HOUR

Compare to the active ingredients in

Claritin-D^® 24 Hour**

ORIGINAL PRESCRIPTION STRENGTH

ALLERGY RELIEF &

NASAL DECONGESTANT

LORATADINE, USP 10 mg / PSEUDOEPHEDRINE SULFATE, USP 240 mg

ANTIHISTAMINE & NASAL DECONGESTANT

NON-DROWSY*

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

*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.

ACTUAL SIZE

10

EXTENDED-

RELEASE TABLETS

Principal Display Panel 15 Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 15 Tablet Blister Pack Carton)

24 HOUR

Compare to the active ingredients of Claritin-D^® 24 Hour**

NDC 11822-9990-5

ORIGINAL PRESCRIPTION STRENGTH

ALLERGY RELIEF &

NASAL DECONGESTANT

LORATADINE, USP 10 mg / PSEUDOEPHEDRINE SULFATE, USP 240 mg

ANTIHISTAMINE & NASAL DECONGESTANT

NON-DROWSY*

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

*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.

ACTUAL SIZE

15

EXTENDED-

RELEASE TABLETS

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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", "42229-5": "Drug Facts", "50565-1": "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).", "50567-7": "When using this product do not take more than directed. Taking more than directed may cause drowsiness.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Active ingredients (in each tablet) Purpose Loratadine, USP 10 mg Antihistamine Pseudoephedrine sulfate, USP 240 mg 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": "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", "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", "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", "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.", "PRINCIPAL DISPLAY PANEL - 10 Tablet Blister Pack Carton": "NDC 11822-9990-0 24 HOUR Compare to the active ingredients in Claritin-D ® 24 Hour** ORIGINAL PRESCRIPTION STRENGTH ALLERGY RELIEF & NASAL DECONGESTANT LORATADINE, USP 10 mg / PSEUDOEPHEDRINE SULFATE, USP 240 mg ANTIHISTAMINE & NASAL DECONGESTANT NON-DROWSY* 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 *WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL. ACTUAL SIZE 10 EXTENDED- RELEASE TABLETS", "PRINCIPAL DISPLAY PANEL - 15 Tablet Blister Pack Carton": "24 HOUR Compare to the active ingredients of Claritin-D ® 24 Hour** NDC 11822-9990-5 ORIGINAL PRESCRIPTION STRENGTH ALLERGY RELIEF & NASAL DECONGESTANT LORATADINE, USP 10 mg / PSEUDOEPHEDRINE SULFATE, USP 240 mg ANTIHISTAMINE & NASAL DECONGESTANT NON-DROWSY* 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 *WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL. ACTUAL SIZE 15 EXTENDED- RELEASE TABLETS"}

Allergy Relief & Nasal Decongestant

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information