cvs pharmacy, inc. 12 hour nasal decongestant drug facts

cvs pharmacy, inc. 12 hour nasal decongestant drug facts
SPL v6
SPL
SPL Set ID 85955336-3f79-457d-822c-f8be019729d1
Route
oral
Published
Effective Date 2019-05-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
pseudoephedrine (120 mg)
Inactive Ingredients
carnauba wax silicon dioxide dibasic calcium phosphate dihydrate hypromelloses magnesium stearate cellulose, microcrystalline polyethylene glycol polysorbate 80 titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: L054 Shape: oval Color: white Size: 18 mm Score: 1
Marketing Status
anda active Since 1999-12-01

Purpose

Nasal decongestant

Description

Pseudoephedrine HCl 120 mg


Medication Information

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.

Active Ingredient

Pseudoephedrine HCl 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
  • each tablet contains: calcium 45 mg
  • store at 20-25°C (68-77°F) in a dry place
  • protect from light
  • do not use if blister unit is broken or torn
  • see carton end panel for lot number and expiration date
  • this product meets the requirements of USP Drug Release Test 3
Inactive Ingredients

carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Description

Pseudoephedrine HCl 120 mg

Principal Display Panel

Compare to the active ingredient in Sudafed® Sinus Congestion 12 Hour Caplets

Non-Drowsy

Sinus

12 Hour Nasal Decongestant

PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 120 mg NASAL DECONGESTANT

MAXIMUM STRENGTH

Sinus Pressure

Congestion

12 HOUR

10 COATED CAPLETS*

*Capsule-shaped tablets

Actual Size

Questions Or Comments?

1-800-719-9260

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).

Ask A Doctor Before Use If You Have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

Structured Label Content

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.

Active Ingredient (Active ingredient (in each tablet))

Pseudoephedrine HCl 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)
  • each tablet contains: calcium 45 mg
  • store at 20-25°C (68-77°F) in a dry place
  • protect from light
  • do not use if blister unit is broken or torn
  • see carton end panel for lot number and expiration date
  • this product meets the requirements of USP Drug Release Test 3
Inactive Ingredients (Inactive ingredients)

carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Principal Display Panel

Compare to the active ingredient in Sudafed® Sinus Congestion 12 Hour Caplets

Non-Drowsy

Sinus

12 Hour Nasal Decongestant

PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 120 mg NASAL DECONGESTANT

MAXIMUM STRENGTH

Sinus Pressure

Congestion

12 HOUR

10 COATED CAPLETS*

*Capsule-shaped tablets

Actual Size

Questions Or Comments? (Questions or comments?)

1-800-719-9260

When Using This Product (When using this product)

do not exceed recommended dosage

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).

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

Advanced Ingredient Data


Raw Label Data

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