Kirkland Signature™

Drug Facts

Composition & Product

Active Ingredients

Loratadine (10 mg) Pseudoephedrine (240 mg)

Inactive Ingredients

Calcium Carbonate Silicon Dioxide Hydroxypropyl Cellulose, Unspecified Hypromellose, Unspecified Ferrosoferric Oxide Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Povidone, Unspecified Propylene Glycol Sodium Alginate Sodium Citrate, Unspecified Form Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance

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

Marketing Status

ANDA Active Since 2017-08-25

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 15 Tablet Blister Pack Carton

KIRKLAND

Signature_™

COMPARE TO

CLARITIN-D^® 24 HOUR

active ingredients**

NDC 63981-724-15

ITM. / ART. 1133953

ALLERGY & CONGESTION

NON-DROWSY*

ALLERCLEAR^® D-24 hr

Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant

Loratadine, USP 10 mg/Antihistamine

Extended-Release Tablets

Indoor & Outdoor Allergies

Actual Size

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.

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 15 Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 15 Tablet Blister Pack Carton)

KIRKLAND

Signature_™

COMPARE TO

CLARITIN-D^® 24 HOUR

active ingredients**

NDC 63981-724-15

ITM. / ART. 1133953

ALLERGY & CONGESTION

NON-DROWSY*

ALLERCLEAR^® D-24 hr

Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant

Loratadine, USP 10 mg/Antihistamine

Extended-Release Tablets

Indoor & Outdoor Allergies

Actual Size

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.

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 - 15 Tablet Blister Pack Carton": "KIRKLAND Signature ™ COMPARE TO CLARITIN-D ® 24 HOUR active ingredients** NDC 63981-724-15 ITM. / ART. 1133953 ALLERGY & CONGESTION NON-DROWSY* ALLERCLEAR ® D-24 hr Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant Loratadine, USP 10 mg/Antihistamine Extended-Release Tablets Indoor & Outdoor Allergies Actual Size 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. 15 EXTENDED RELEASE TABLETS"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information