american sales company nasal & sinus decongestant drug facts

american sales company nasal & sinus decongestant drug facts
SPL v3
SPL
SPL Set ID 81b31070-9b03-4ce4-8aac-a334544842ae
Route
oral
Published
Effective Date 2017-07-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
pseudoephedrine (30 mg)
Inactive Ingredients
carnauba wax dibasic calcium phosphate dihydrate hypromellose, unspecified magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified polysorbate 80 silicon dioxide titanium dioxide fd&c red no. 40

Identifiers & Packaging

Pill Appearance
Imprint: L432 Shape: round Color: red Size: 7 mm Score: 1
Marketing Status
otc monograph drug active Since 2017-09-25 Until 2017-09-25

Purpose

Nasal decongestant

Description

Pseudoephedrine HCl 30 mg


Medication Information

Active Ingredient

Pseudoephedrine HCl 30 mg

Uses
  • temporarily relieves sinus congestion and pressure
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
Purpose

Nasal decongestant

Directions

adults and children 12

years and over

  • take 2 tablets every 4 to 6 hours
  • do not take more than 8 tablets in 24 hours

children ages 6 to 11

years

  • take 1 tablet every 4 to 6 hours
  • do not take more than 4 tablets in 24 hours

children under 6 years

do not use this product in children under 6 years of age

Other Information
  • each tablet contains: calcium 20 mg
  • store at 20°-25°C (68°-77°F)
  • do not use if blister unit is broken or torn.
Inactive Ingredients

carnauba wax, dibasic calcium phosphate dihydrate, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, silicon dioxide, titanium dioxide

Description

Pseudoephedrine HCl 30 mg

Principal Display Panel

Compare to the active ingredient in Sudafed® Congestion

NASAL & SINUS DECONGESTANT

Pseudoephedrine HCl Tablets, 30 mg

Nasal Decongestant

Maximum Strength

Sinus Pressure

Congestion

Non-Drowsy

Actual Size

OUR PHARMACISTS RECOMMEND

24 TABLETS

30 mg EACH

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.

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

Active Ingredient (Active ingredient (in each tablet))

Pseudoephedrine HCl 30 mg

Uses
  • temporarily relieves sinus congestion and pressure
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
Purpose

Nasal decongestant

Directions

adults and children 12

years and over

  • take 2 tablets every 4 to 6 hours
  • do not take more than 8 tablets in 24 hours

children ages 6 to 11

years

  • take 1 tablet every 4 to 6 hours
  • do not take more than 4 tablets in 24 hours

children under 6 years

do not use this product in children under 6 years of age

Other Information (Other information)
  • each tablet contains: calcium 20 mg
  • store at 20°-25°C (68°-77°F)
  • do not use if blister unit is broken or torn.
Inactive Ingredients (Inactive ingredients)

carnauba wax, dibasic calcium phosphate dihydrate, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, silicon dioxide, titanium dioxide

Principal Display Panel

Compare to the active ingredient in Sudafed® Congestion

NASAL & SINUS DECONGESTANT

Pseudoephedrine HCl Tablets, 30 mg

Nasal Decongestant

Maximum Strength

Sinus Pressure

Congestion

Non-Drowsy

Actual Size

OUR PHARMACISTS RECOMMEND

24 TABLETS

30 mg EACH

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.

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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