Heb 44-453

Heb 44-453
SPL v14
SPL
SPL Set ID 7c04ab14-af28-4598-90ef-56ac11902c7d
Route
ORAL
Published
Effective Date 2025-12-04
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 Lecithin, Soybean Magnesium Stearate Maltodextrin Microcrystalline Cellulose Silicon Dioxide Carboxymethylcellulose Sodium, Unspecified Trisodium Citrate Dihydrate Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;453 Shape: round Color: red Size: 7 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2005-01-14

Description

Phenylephrine HCl 10 mg

Purpose

Nasal decongestant


Medication Information

Purpose

Nasal decongestant

Description

Phenylephrine HCl 10 mg

Uses
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • temporarily relieves sinus congestion and pressure 
Directions
  • adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
  • children under 12 years: ask a doctor
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.

Other Information
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 
Inactive Ingredients

croscarmellose sodium, dextrose monohydrate, dibasic calcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide

Questions Or Comments?

1-800-426-9391

Principal Display Panel

Compare to Sudafed PE® Congestion 

active ingredient*

NDC 37808-453-23

H-E-B®

Maximum Strength

Nasal

Decongestant PE

Phenylephrine HCl 10 mg /

Nasal Decongestant

Sinus Decongestant

Non-Drowsy

Relief of:

• Congestion

• Sinus Pressure

actual

size

72 TABLETS

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Johnson & Johnson

Corporation, owner of the registered trademark Sudafed PE® Sinus

Congestion.         50844      REV0820B45323

MADE WITH PRIDE AND CARE FOR H-E-B®

SAN ANTONIO, TX 78204

H-E-B®

100%

GUARANTEE

promise

If you aren't completely pleased

with this product, we'll be happy to

replace it or refund your money.

You have our word on it.

HEB 44-453
When Using This Product

do not exceed recommended dosage.

Stop Use and Ask A Doctor If
  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or occur with fever
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.

Active Ingredient (in Each Tablet)

Phenylephrine HCl 10 mg

Ask A Doctor Before Use If You Have
  • heart disease
  • diabetes

  • thyroid disease
  • high blood pressure

  • difficulty in urination due to enlargement of the prostate gland 

Structured Label Content

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

Nasal decongestant

Directions
  • adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
  • children under 12 years: ask a doctor
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.

Other Information (Other information)
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 
Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, dextrose monohydrate, dibasic calcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

Compare to Sudafed PE® Congestion 

active ingredient*

NDC 37808-453-23

H-E-B®

Maximum Strength

Nasal

Decongestant PE

Phenylephrine HCl 10 mg /

Nasal Decongestant

Sinus Decongestant

Non-Drowsy

Relief of:

• Congestion

• Sinus Pressure

actual

size

72 TABLETS

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Johnson & Johnson

Corporation, owner of the registered trademark Sudafed PE® Sinus

Congestion.         50844      REV0820B45323

MADE WITH PRIDE AND CARE FOR H-E-B®

SAN ANTONIO, TX 78204

H-E-B®

100%

GUARANTEE

promise

If you aren't completely pleased

with this product, we'll be happy to

replace it or refund your money.

You have our word on it.

HEB 44-453
When Using This Product (When using this product)

do not exceed 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 occur with fever
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.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Phenylephrine HCl 10 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease
  • diabetes

  • thyroid disease
  • high blood pressure

  • difficulty in urination due to enlargement of the prostate gland 

Advanced Ingredient Data


Raw Label Data

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