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

Purpose

Nasal decongestant

Description

Pseudoephedrine HCl 30 mg


Medication Information

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

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

Description

Pseudoephedrine HCl 30 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.

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

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

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.

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

All Sections (JSON)