PSEUDOEPHEDRINE HYDROCHLORIDE tablet, film coated

Pseudoephedrine hydrochloride by

Drug Labeling and Warnings

Pseudoephedrine hydrochloride by is a Otc medication manufactured, distributed, or labeled by STRATEGIC SOURCING SERVICES LLC, Ohm Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Pseudoephedrine HCl, USP 120 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 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 1 tablet every 12 hours
  • do not take more than 2 tablets in 24 hours
• children under 12 years: do not use this product in children under 12 years of age

Other information

• store at 59° to 77° F in a dry place. Protect from light
• TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Inactive ingredients

castor oil, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, magnesium stearate, titanium dioxide

Questions?

Call 833-358-6431 M - F, 9AM - 7PM EST

SPL UNCLASSIFIED SECTION

Distributed by: McKesson Corp., via Strategic
Sourcing Services LLC. Memphis, TN 38141

PRINCIPAL DISPLAY PANEL - 120 mg Tablet Blister Pack Carton

NDC: 70677-1019-1

COMPARE TO SUDAFED®
SINUS CONGESTION 12 HOUR ACTIVE INGREDIENT*

Foster & Thrive™

MAXIMUM STRENGTH

Nasal Decongestant

Pseudoephedrine Hydrochloride 120 mg
Extended-Release Tablets, USP
Long-Acting Nasal Decongestant

Non-Drowsy

12 hour

• Sinus Pressure + Congestion

ACTUAL SIZE

10 Coated Capsule-Shaped Tablets 120 mg Each

INGREDIENTS AND APPEARANCE

PSEUDOEPHEDRINE HYDROCHLORIDE 
pseudoephedrine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70677-1019
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	120 mg

Inactive Ingredients
Ingredient Name	Strength
CASTOR OIL (UNII: D5340Y2I9G)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	204
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70677-1019-1	1 in 1 CARTON	08/10/2023
1		10 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
ANDA	ANDA077442	08/10/2023

Labeler - STRATEGIC SOURCING SERVICES LLC (116956644)

Registrant - Ohm Laboratories Inc. (184769029)

Establishment
Name	Address	ID/FEI	Business Operations
Ohm Laboratories Inc.		051565745	manufacture(70677-1019)