NASAL DECONGESTANT- pseudoephedrine hcl tablet

Nasal Decongestant by

Drug Labeling and Warnings

Nasal Decongestant by is a Otc medication manufactured, distributed, or labeled by Proficient Rx LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

• Pseudoephedrine HCl 30 mg

Purpose

• Nasal Congestant

Use(s)

• temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
• temporarily restores freer breathing through the nose

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 2 weeks after stoppin the MAOI drug.  If you do not know if your prescription drug contains and MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

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

When using this product

• do not use more than directed

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 (1-800-222-1222).

Directions

• adults and children12 years and older:

  take 2 tablets every 4 to 6 hours;; do not take more than 8 tablets in; 24 hours

• children ages 6 to 12 years:

  take 1 tablet every 4 to 6 hours;; do not take more than 4 tablets in; 24 hours

• children under 6 years:

  do not use

Other information

• store at room temperature 15º-30ºC (59º-86ºF)

Inactive ingredients

• calcium sulfate, carnauba wax, croscarmellose sodium, FD&C red #40 lake, FD&C yellow #6 lake, gelatin, kaolin, lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, silica, stearic acid, sugar and titanium dioxide

Questions or comments?

1-800-645-2158

Principal Display Panel

Rugby®

compare to Sudafed®

Decongestant active ingredient*

NDC: 63187-344-24

Nasal Decongestant

pseudoephedrine HCl 30 mg

Temporarily relieves:

nasal congestion due to cold & allergies withoout drowsiness

24 tablets, 30 mg each

TAMPER EVIDENT: SAFETY SEALED: DO NOT USE IF BLISTER SEAL IS BROKEN

Rev 04/13

R-29

DISTRIBUTED BY:
Rugby Laboratories
31778 Enterprise Drive
Livonia, MI 48150
www.rugbylaboratories.com

Repackaged by:
Proficient Rx LP
Thousand Oaks, CA 91320

INGREDIENTS AND APPEARANCE

NASAL DECONGESTANT 
pseudoephedrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63187-344(NDC:0536-3607)
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CALCIUM SULFATE, UNSPECIFIED FORM (UNII: WAT0DDB505)
CARNAUBA WAX (UNII: R12CBM0EIZ)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
KAOLIN (UNII: 24H4NWX5CO)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
SHELLAC (UNII: 46N107B71O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
12-HYDROXYSTEARIC ACID (UNII: 933ANU3H2S)
ACER SACCHARUM POLLEN (UNII: V38QUQ7861)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	1004
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63187-344-24	1 in 1 CARTON	03/03/2014
1		24 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/29/2012

Labeler - Proficient Rx LP (079196022)

Establishment
Name	Address	ID/FEI	Business Operations
Proficient Rx LP		079502574	RELABEL(63187-344)