PSEUDOEPHEDRINE HYDROCHLORIDE- pseudoephedrine hcl tablet, film coated

pseudoephedrine hydrochloride by

Drug Labeling and Warnings

pseudoephedrine hydrochloride 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 decongestant

Uses

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

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 occur
• 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 tablets every 4 to 6 hours
  • do not take more than 8 tablets in 24 hours
• children ages 6 to 11 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 this product in children under 6 years of age

Other information

• each tablet contains: calcium 20 mg
• store at 20°-25°C (68°-77°F)
• do not use if blister unit is broken or torn

Inactive ingredients

carnauba wax, dibasic calcium phosphate dihydrate, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, silicon dioxide, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Sudafed® Congestion active ingredient

Pseudoephedrine Hydrochloride

30 mg

Nasal Decongestant

Maximum Strength – Non-Drowsy

Sinus Pressure – Congestion

24 TABLETS, 30 mg EACH

Pseudoephedrine HCl – Sinus

actual size

Congestion

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

INGREDIENTS AND APPEARANCE

PSEUDOEPHEDRINE HYDROCHLORIDE 
pseudoephedrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71205-197(NDC:45802-432)
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
CARNAUBA WAX (UNII: R12CBM0EIZ)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND (convex)	Size	7mm
Flavor		Imprint Code	L432
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71205-197-24	24 in 1 CARTON	01/01/2019
1		1 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	10/17/2008

Labeler - Proficient Rx LP (079196022)

Establishment
Name	Address	ID/FEI	Business Operations
Proficient Rx LP		079196022	REPACK(71205-197) , RELABEL(71205-197)