pseudoephedrine hydrochloride

pseudoephedrine hydrochloride
SPL v4
SPL
SPL Set ID 918b2a90-532b-4358-bdff-9ad48c167a7e
Route
oral
Published
Effective Date 2020-08-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
pseudoephedrine (120 mg)
Inactive Ingredients
hypromellose, unspecified silicon dioxide microcrystalline cellulose magnesium stearate titanium dioxide castor oil

Identifiers & Packaging

Pill Appearance
Imprint: 204 Shape: capsule Color: white Size: 18 mm Score: 1
Marketing Status
anda active Since 2017-02-20

Purpose

Nasal decongestant

Description

Drug Facts


Medication Information

Active Ingredient

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
Purpose

Nasal decongestant

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

Description

Drug Facts

Questions?

call 1-800-406-7984

Section 42229-5

Drug Facts

Section 50565-1

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)

Section 50567-7

When using this product do not exceed recommended dosage

Section 50570-1

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.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Stop Use and Ask A Doctor If
  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or occur with a fever
Ask A Doctor Before Use If You Have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
Principal Display Panel 120 Mg Tablet Blister Pack Carton

NDC 62011-0306-1

Health Mart®

Compare to Sudafed® 12 Hour

active ingredient*

MAXIMUM STRENGTH

Nasal Decongestant

Pseudoephedrine Hydrochloride 120 mg

Extended-Release Tablets, USP

Long-Acting Nasal Decongestant

12 Hour • Non-Drowsy

SINUS PRESSURE + CONGESTION

ACTUAL SIZE

10 Coated Capsule-Shaped Tablets 120 mg Each


Structured Label Content

Active Ingredient (Active ingredient (in each tablet))

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
Purpose

Nasal decongestant

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 (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 (Inactive ingredients)

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

Questions?

call 1-800-406-7984

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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)

Section 50567-7 (50567-7)

When using this product do not exceed recommended dosage

Section 50570-1 (50570-1)

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.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

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
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
Principal Display Panel 120 Mg Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 120 mg Tablet Blister Pack Carton)

NDC 62011-0306-1

Health Mart®

Compare to Sudafed® 12 Hour

active ingredient*

MAXIMUM STRENGTH

Nasal Decongestant

Pseudoephedrine Hydrochloride 120 mg

Extended-Release Tablets, USP

Long-Acting Nasal Decongestant

12 Hour • Non-Drowsy

SINUS PRESSURE + CONGESTION

ACTUAL SIZE

10 Coated Capsule-Shaped Tablets 120 mg Each


Advanced Ingredient Data


Raw Label Data

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