SPL v2
SPL
SPL Set ID e6731360-a309-1652-6c43-5235076c18a4
Route
ORAL
Published
Effective Date 2010-09-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (10 mg)
Inactive Ingredients
Croscarmellose Sodium Dextrose Monohydrate Dibasic Calcium Phosphate Dihydrate Fd&c Red No. 40 Magnesium Stearate Maltodextrin Cellulose, Microcrystalline Silicon Dioxide Carboxymethylcellulose Sodium Trisodium Citrate Dihydrate

Identifiers & Packaging

Pill Appearance
Imprint: 44;453 Shape: round Color: red Size: 6 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2004-12-06

Description

(in each tablet) Phenylephrine HCl 10 mg

Purpose

Nasal decongestant


Medication Information

Purpose

Nasal decongestant

Description

(in each tablet) Phenylephrine HCl 10 mg

Uses
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • temporarily relives sinus congestion and pressure
Directions
  • adults and children 12 years and over: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours. 
  • children under 12 years: do not use this product in children under 12 years of age
Do Not Use

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.

Active Ingredient

(in each tablet)

Phenylephrine HCl 10 mg

Other Information
  • store at controlled room temperature 15°-30°C (59° to 86°F)
  • see end flap for expiration date and lot number
Product Packaging

The product packaging shown below represents a sample of that currently in use. Additional packaging may aslo be available.

KIRKLAND

Signature™

COMPARE TO

SUDAFED PE™

active ingredient*

NDC 63981-453-69

ITEM # 111266

NON-DROWSY

SUPHEDRINE PE

Phenylephrine Hydrochloride 10 mg

Nasal & Sinus Decongestant Formula

Temporary Relief of:

Nasal Congestion

Sinus Pressure & Congestion

Hay Fever Symptoms

Actual Size

1 Pill Per Dose

144

TABLETS

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

50844       REV0810F45369

Manufactured by:

LNK INTERNATIONAL, INC.

60 Arkay Drive, Hauppauge, NY 11788 USA

For Costco Wholesale Corporation

P.O. Box 34535

Seattle, WA 98124-1535 USA

1-800-774-2678

www.cvs.com

Inactive Ingredients

croscarmellose sodium, dextrose monohydrate, dicalcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silica gel, sodium cardoxymethylcellulose, sodium citrate dihydrate, titanium dioxide

When Using This Product

do not exceed the recommended dosage

Stop Use and Ask A Doctor If
  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or are accompanied by fever
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of the Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have
  • heart disease
  • high blood pressure
  • diabetes
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland

Structured Label Content

Uses
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • temporarily relives sinus congestion and pressure
Purpose

Nasal decongestant

Directions
  • adults and children 12 years and over: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours. 
  • children under 12 years: do not use this product in children under 12 years of age
Do Not Use (Do not use)

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.

Active Ingredient (Active ingredient)

(in each tablet)

Phenylephrine HCl 10 mg

Other Information (Other information)
  • store at controlled room temperature 15°-30°C (59° to 86°F)
  • see end flap for expiration date and lot number
Product Packaging (PRODUCT PACKAGING)

The product packaging shown below represents a sample of that currently in use. Additional packaging may aslo be available.

KIRKLAND

Signature™

COMPARE TO

SUDAFED PE™

active ingredient*

NDC 63981-453-69

ITEM # 111266

NON-DROWSY

SUPHEDRINE PE

Phenylephrine Hydrochloride 10 mg

Nasal & Sinus Decongestant Formula

Temporary Relief of:

Nasal Congestion

Sinus Pressure & Congestion

Hay Fever Symptoms

Actual Size

1 Pill Per Dose

144

TABLETS

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

50844       REV0810F45369

Manufactured by:

LNK INTERNATIONAL, INC.

60 Arkay Drive, Hauppauge, NY 11788 USA

For Costco Wholesale Corporation

P.O. Box 34535

Seattle, WA 98124-1535 USA

1-800-774-2678

www.cvs.com

Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, dextrose monohydrate, dicalcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silica gel, sodium cardoxymethylcellulose, sodium citrate dihydrate, titanium dioxide

When Using This Product (When using this product)

do not exceed the recommended dosage

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or are accompanied by fever
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of the Reach of Children. (Keep out of the reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease
  • high blood pressure
  • diabetes
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland

Advanced Ingredient Data


Raw Label Data

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