american sales company nasal & sinus decongestant drug facts

american sales company nasal & sinus decongestant drug facts
SPL v4
SPL
SPL Set ID a5aa414c-a143-44c8-9759-e84c0f032fbf
Route
oral
Published
Effective Date 2023-10-30
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 hypromellose, unspecified magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified polysorbate 80 titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: L054 Shape: oval Color: white Size: 18 mm Score: 1
Marketing Status
anda active Since 2016-09-15

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

CAREone®

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

NASAL & SINUS DECONGESTANT

Pseudoephedrine Hydrochloride Extended Release Tablets, 120 mg

Nasal Decongestant

Maximum Strength

Sinus Pressure

Congestion

Actual Size

Non-Drowsy

12hr

OUR PHARMACISTS RECOMMEND

20 COATED CAPLETS*

*Capsule-Shaped Tablets

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

CAREone®

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

NASAL & SINUS DECONGESTANT

Pseudoephedrine Hydrochloride Extended Release Tablets, 120 mg

Nasal Decongestant

Maximum Strength

Sinus Pressure

Congestion

Actual Size

Non-Drowsy

12hr

OUR PHARMACISTS RECOMMEND

20 COATED CAPLETS*

*Capsule-Shaped Tablets

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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