Zephrex D Drug Facts

Zephrex D Drug Facts
SPL v5
SPL
SPL Set ID 5468a7e2-361b-494f-9ca3-1b62f3819f65
Route
ORAL
Published
Effective Date 2024-11-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pseudoephedrine (30 mg)
Inactive Ingredients
Croscarmellose Sodium Fd&c Red No. 40 Gelatin, Unspecified Guar Gum Hydroxypropyl Cellulose (1600000 Wamw) Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polysorbate 80 Water Sorbitan Sorbitol Titanium Dioxide Xanthan Gum

Identifiers & Packaging

Pill Appearance
Imprint: ZD3 Shape: oval Color: red Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-11-04

Description

Pseudoephedrine HCl 30 mg

Purpose

Nasal decongestant


Medication Information

Purpose

Nasal decongestant

Description

Pseudoephedrine HCl 30 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 2 softgels every 4 to 6 hours
  • do not take more than 8 softgels in 24 hours

children ages 6 to under 12 years

  • take 1 softgel every 4 to 6 hours
  • do not take more than 4 softgels in 24 hours

children under 6 years

do not use this product in children under 6 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.

Other Information
  • store at 20-25°C (68-77°F)
  • do not use if blister unit is broken or torn
Inactive Ingredients

croscarmellose sodium, FD&C red no. 40, gelatin, guar gum, hydroxypropylcellulose, lecithin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, purified water, sorbitan, sorbitol, titanium dioxide, vegetable oil, xanthan gum

Questions Or Comments?

1-800-719-9260

When Using This Product

do not exceed recommended dosage

Stop Use and Ask A Doctor If
  • nervousness, dizziness, or sleeplessness occurs
  • symptoms do not improve within 7 days or occur with a 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 (1-800-222-1222).

Active Ingredient (in Each Softgel)

Pseudoephedrine HCl 30 mg

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

NEW DOSAGE FORM

MAXIMUM STRENGTH

ZEPHREX-D ®

CONGESTION

Pseudoephedrine HCl 30 mg

Nasal Decongestant

METH BLOCKING TAREX® TECHNOLOGY ™

Non-Drowsy

Relieves

Nasal & Sinus Congestion

Sinus Pressure

Easy-to-take softgels.

Individually sealed.

Actual Size

Fast-acting nasal decongestant goes to work in as little as 30 minutes. With advanced meth-blocking technology for safer communities.

24 softgels


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 2 softgels every 4 to 6 hours
  • do not take more than 8 softgels in 24 hours

children ages 6 to under 12 years

  • take 1 softgel every 4 to 6 hours
  • do not take more than 4 softgels in 24 hours

children under 6 years

do not use this product in children under 6 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.

Other Information (Other information)
  • store at 20-25°C (68-77°F)
  • do not use if blister unit is broken or torn
Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, FD&C red no. 40, gelatin, guar gum, hydroxypropylcellulose, lecithin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, purified water, sorbitan, sorbitol, titanium dioxide, vegetable oil, xanthan gum

Questions Or Comments? (Questions or comments?)

1-800-719-9260

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 occurs
  • symptoms do not improve within 7 days or occur with a 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 (1-800-222-1222).

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Pseudoephedrine HCl 30 mg

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

NEW DOSAGE FORM

MAXIMUM STRENGTH

ZEPHREX-D ®

CONGESTION

Pseudoephedrine HCl 30 mg

Nasal Decongestant

METH BLOCKING TAREX® TECHNOLOGY ™

Non-Drowsy

Relieves

Nasal & Sinus Congestion

Sinus Pressure

Easy-to-take softgels.

Individually sealed.

Actual Size

Fast-acting nasal decongestant goes to work in as little as 30 minutes. With advanced meth-blocking technology for safer communities.

24 softgels


Advanced Ingredient Data


Raw Label Data

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