American Sales Company Nasal & Sinus Decongestant Drug Facts

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

Medication Information

Purpose

Nasal decongestant

Description

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

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

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 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

Questions Or Comments?

1-800-719-9260

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

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).

Active Ingredient (in Each Tablet)

Pseudoephedrine HCl 30 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

Structured Label Content

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

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 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

Questions Or Comments? (Questions or comments?)

1-800-719-9260

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

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).

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Pseudoephedrine HCl 30 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

Advanced Ingredient Data

[{"name": "PSEUDOEPHEDRINE", "unii": "7CUC9DDI9F", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CARNAUBA WAX", "unii": "R12CBM0EIZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIBASIC CALCIUM PHOSPHATE DIHYDRATE", "unii": "O7TSZ97GEP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "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 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", "Questions or comments?": "1-800-719-9260", "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", "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).", "Active ingredient (in each tablet)": "Pseudoephedrine HCl 30 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"}

American Sales Company Nasal & Sinus Decongestant Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information