OTC Medication Information: Zephrex D

ZEPHREX D- pseudoephedrine hydrochloride capsule, gelatin coated
L. Perrigo Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient (in each softgel)

Pseudoephedrine HCl 30 mg

Purpose

Nasal decongestant

Uses

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

Warnings

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.

Ask a doctor before use if you have

heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland

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).

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

Questions or comments?

1-800-719-9260

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

Zephrex-D image
(click image for full-size original)
ZEPHREX D
pseudoephedrine hydrochloride capsule, gelatin coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0113-0401
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg
Inactive Ingredients
Ingredient Name Strength
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
Product Characteristics
Color RED Score no score
Shape OVAL Size 17mm
Flavor Imprint Code ZD3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0113-0401-62 24 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK This package is contained within the CARTON (0113-0401-62)
2 NDC:0113-0401-67 48 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK This package is contained within the CARTON (0113-0401-67)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 11/04/2016
Labeler — L. Perrigo Company (006013346)

Revised: 11/2020 L. Perrigo Company

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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