e6731360-a309-1652-6c43-5235076c18a4

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

Purpose

Nasal decongestant

Description

(in each tablet) Phenylephrine HCl 10 mg


Medication Information

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

Description

(in each tablet) Phenylephrine HCl 10 mg

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

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

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
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
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

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

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

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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