ZEPHREX D- pseudoephedrine hydrochloride capsule, gelatin coated

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).

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?

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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
pseudoephedrine hydrochloride capsule, gelatin coated

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GUAR GUM (UNII: E89I1637KE)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 0113-0401-62	24 in 1 CARTON	04/17/2017
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0113-0401-67	48 in 1 CARTON	05/08/2017
2		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	11/04/2016

Labeler - L. Perrigo Company (006013346)

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