PSEUDOEPHEDRINE HCL- pseudoephedrine hydrochloride tablet

Pseudoephedrine HCL by

Drug Labeling and Warnings

Pseudoephedrine HCL by is a Otc medication manufactured, distributed, or labeled by Innovida Pharmaeutique Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each tablet)

Pseudoephedrine HCl 60 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 useif 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

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

When using this product do not exceed recommended dose.

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.

KEEP OUT OF REACH OF CHILDREN

Directions

• adults and children 12 years and older: take 1 tablet every 4 to 6 hours. Do not take more than 4 tablets in 24 hours.
• children under 12 years of age: do not use

Other Information

• Store in a dry place at 15°-30°C (59°-86°F) 
• keep lid tightly closed

Inactive Ingredients

croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, silica and stearic acid

Questions or Comments? 1-888-462-4166

Product label

INGREDIENTS AND APPEARANCE

PSEUDOEPHEDRINE HCL 
pseudoephedrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71800-053
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	60 mg

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white (Off White)	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71800-053-07	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/10/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	02/10/2025

Labeler - Innovida Pharmaeutique Corporation (080892908)