Perrigo Suphedrine 12 Hour Drug Facts

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 1999-10-29

Medication Information

Purpose

Nasal decongestant

Description

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

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.

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

Questions Or Comments?

1-800-719-9260

Principal Display Panel

GOODSENSE_®

Maximum Strength

Sinus

Non-Drowsy

Suphedrine 12 Hour

Pseudoephedrine Hydrochloride Extended-Release Tablets, 120 mg

Actual Size

Nasal Decongestant

• Sinus Pressure

• Congestion

Compare to active ingredient of Sudafed® Sinus Congestion 12 Hour Caplets

10 Coated Caplets* (120 mg Each)

*Capsule-Shaped Tablets

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

Purpose

Nasal decongestant

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.

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

Questions Or Comments? (Questions or comments?)

1-800-719-9260

Principal Display Panel

GOODSENSE_®

Maximum Strength

Sinus

Non-Drowsy

Suphedrine 12 Hour

Pseudoephedrine Hydrochloride Extended-Release Tablets, 120 mg

Actual Size

Nasal Decongestant

• Sinus Pressure

• Congestion

Compare to active ingredient of Sudafed® Sinus Congestion 12 Hour Caplets

10 Coated Caplets* (120 mg Each)

*Capsule-Shaped Tablets

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 120 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": "120", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CARNAUBA WAX", "unii": "R12CBM0EIZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "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": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "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.", "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", "Questions or comments?": "1-800-719-9260", "Principal Display Panel": "GOODSENSE ® Maximum Strength Sinus Non-Drowsy Suphedrine 12 Hour Pseudoephedrine Hydrochloride Extended-Release Tablets, 120 mg Actual Size Nasal Decongestant • Sinus Pressure • Congestion Compare to active ingredient of Sudafed® Sinus Congestion 12 Hour Caplets 10 Coated Caplets* (120 mg Each) *Capsule-Shaped Tablets", "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 120 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"}

Perrigo Suphedrine 12 Hour Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information