Pseudoephedrine Hcl Extended-release Tablets Usp 120 Mg
f9d5a22a-3964-08b8-e053-6294a90ab220
34390-5
Human OTC Drug Label
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Pseudoephedrine HCl USP 120 mg
Purpose
Nasal decongestant
Medication Information
Purpose
Nasal decongestant
Description
Pseudoephedrine HCl USP 120 mg
Uses
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- temporarily relieves sinus congestion and pressure
Directions
| adults and children 12 years and over |
|
| children under 12 years
|
do not use this product in children under 12 years of age |
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.
Other Information
- Each tablet contains: calcium 36 mg
- store at 20° to 25°C (68° to 77°F). Protect from light.
- do not use if the individual blister unit is open or torn
- see side panel for lot number and expiration date
- Meets USP dissolution test 4
Inactive Ingredients
colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, and titanium dioxide.
Questions Or Comments?
call 1-855-274-4122
DISTRIBUTED BY:
BETTER LIVING BRANDS LLC
P.O.BOX 99
PLEASANTON, CA 94566-0009
‡1-888-723-3929
Made in India
Code: TS/DRUGS/22/2009
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)
Active Ingredient (in Each Tablet)
Pseudoephedrine HCl USP 120 mg
Ask A Doctor Before Use If You Have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
Package Label Principal Display Panel 120 Mg, Blister Carton 20 (2 X 10) extended Release Tablets
Compare to the
Sudafed® 12 Hour**
active ingredient
NDC 21130-158-67
12 HOUR
MAXIMUM STRENGTH
Long-Acting
Nasal Decongestant
PSEUDOEPHEDRINE HCl
Extended-Release Tablets USP
120 mg
• SINUS PRESSURE
• CONGESTION
• NON-DROWSY
20 COATED CAPLETS*
120 mg EACH
*CAPSULE-SHAPED TABLETS
Structured Label Content
Uses
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- temporarily relieves sinus congestion and pressure
Purpose
Nasal decongestant
Directions
| adults and children 12 years and over |
|
| children under 12 years
|
do not use this product in children under 12 years of age |
Do Not Use (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.
Other Information (Other information)
- Each tablet contains: calcium 36 mg
- store at 20° to 25°C (68° to 77°F). Protect from light.
- do not use if the individual blister unit is open or torn
- see side panel for lot number and expiration date
- Meets USP dissolution test 4
Inactive Ingredients (Inactive ingredients)
colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, and titanium dioxide.
Questions Or Comments? (Questions or comments?)
call 1-855-274-4122
DISTRIBUTED BY:
BETTER LIVING BRANDS LLC
P.O.BOX 99
PLEASANTON, CA 94566-0009
‡1-888-723-3929
Made in India
Code: TS/DRUGS/22/2009
Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)
ask a health professional before use.
Keep Out of Reach of Children. (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)
Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))
Pseudoephedrine HCl USP 120 mg
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
Package Label Principal Display Panel 120 Mg, Blister Carton 20 (2 X 10) extended Release Tablets (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 120 mg, Blister Carton 20 (2 X 10) Extended-Release Tablets)
Compare to the
Sudafed® 12 Hour**
active ingredient
NDC 21130-158-67
12 HOUR
MAXIMUM STRENGTH
Long-Acting
Nasal Decongestant
PSEUDOEPHEDRINE HCl
Extended-Release Tablets USP
120 mg
• SINUS PRESSURE
• CONGESTION
• NON-DROWSY
20 COATED CAPLETS*
120 mg EACH
*CAPSULE-SHAPED TABLETS
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:03:19.762219 · Updated: 2026-03-14T23:03:21.577672