Equaline 44-112

Drug Facts

Composition & Product

Active Ingredients

Pseudoephedrine (30 mg)

Inactive Ingredients

Croscarmellose Sodium Fd&c Yellow No. 6 Magnesium Stearate Microcrystalline Cellulose Titanium Dioxide Calcium Sulfate, Unspecified Form Carnauba Wax Fd&c Red No. 40 Gelatin, Unspecified Kaolin Anhydrous Lactose Magnesium Silicate Shellac Silicon Dioxide 12-hydroxystearic Acid Acer Saccharum Pollen

Identifiers & Packaging

Pill Appearance

Imprint: 1004 Shape: round Color: red Size: 8 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2012-10-29

Medication Information

Purpose

•
Nasal Congestant

Description

• Pseudoephedrine HCl 30 mg

Use(s)

•
temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
•
temporarily restores freer breathing through the nose

Directions

adults and children 12 years and older	take 2 tablets every 4 to 6 hours; do not take more than 8 tablets in 24 hours
children ages 6 to 12 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

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 2 weeks after stoppin the MAOI drug. If you do not know if your prescription drug contains and MAOI, ask a doctor or pharmacist before taking this product.

Other Information

•
store at room temperature 15º-30ºC (59º-86ºF)

Inactive Ingredients

•
calcium sulfate, carnauba wax, croscarmellose sodium, FD&C red #40 lake, FD&C yellow #6 lake, gelatin, kaolin, lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, silica, stearic acid, sugar and titanium dioxide

Questions Or Comments?

1-800-645-2158

Principal Display Panel

Rugby®

compare to Sudafed®

Decongestant active ingredient*

NDC 63187-344-24

Nasal Decongestant

pseudoephedrine HCl 30 mg

Temporarily relieves:

• nasal congestion due to cold & allergies withoout drowsiness

24 tablets, 30 mg each

TAMPER EVIDENT: SAFETY SEALED: DO NOT USE IF BLISTER SEAL IS BROKEN

Rev 04/13

R-29

DISTRIBUTED BY:

Rugby Laboratories

31778 Enterprise Drive

Livonia, MI 48150

Error! Hyperlink reference not valid.

Repackaged by:

Proficient Rx LP

Thousand Oaks, CA 91320

When Using This Product

•
do not use more than directed

Stop Use and Ask A Doctor If

•
nervousness, dizziness, or sleeplessness occur
•
symptoms do not improve within 7 days or occur with 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

•
diabetes
•
high blood pressure
•
heart disease
•
thyroid disease
•
trouble urinating due to an enlarged prostate gland

Structured Label Content

Use(s)

•
temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
•
temporarily restores freer breathing through the nose

Purpose

•
Nasal Congestant

Directions

adults and children 12 years and older	take 2 tablets every 4 to 6 hours; do not take more than 8 tablets in 24 hours
children ages 6 to 12 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

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 2 weeks after stoppin the MAOI drug. If you do not know if your prescription drug contains and MAOI, ask a doctor or pharmacist before taking this product.

Other Information (Other information)

•
store at room temperature 15º-30ºC (59º-86ºF)

Inactive Ingredients (Inactive ingredients)

•
calcium sulfate, carnauba wax, croscarmellose sodium, FD&C red #40 lake, FD&C yellow #6 lake, gelatin, kaolin, lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, silica, stearic acid, sugar and titanium dioxide

Questions Or Comments? (Questions or comments?)

1-800-645-2158

Principal Display Panel

Rugby®

compare to Sudafed®

Decongestant active ingredient*

NDC 63187-344-24

Nasal Decongestant

pseudoephedrine HCl 30 mg

Temporarily relieves:

• nasal congestion due to cold & allergies withoout drowsiness

24 tablets, 30 mg each

TAMPER EVIDENT: SAFETY SEALED: DO NOT USE IF BLISTER SEAL IS BROKEN

Rev 04/13

R-29

DISTRIBUTED BY:

Rugby Laboratories

31778 Enterprise Drive

Livonia, MI 48150

Error! Hyperlink reference not valid.

Repackaged by:

Proficient Rx LP

Thousand Oaks, CA 91320

When Using This Product (When using this product)

•
do not use more than directed

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 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)

•
diabetes
•
high blood pressure
•
heart disease
•
thyroid disease
•
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": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "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": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALCIUM SULFATE, UNSPECIFIED FORM", "unii": "WAT0DDB505", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARNAUBA WAX", "unii": "R12CBM0EIZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN, UNSPECIFIED", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "KAOLIN", "unii": "24H4NWX5CO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS LACTOSE", "unii": "3SY5LH9PMK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM SILICATE", "unii": "9B9691B2N9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SHELLAC", "unii": "46N107B71O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "12-HYDROXYSTEARIC ACID", "unii": "933ANU3H2S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACER SACCHARUM POLLEN", "unii": "V38QUQ7861", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use(s)": "• temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • temporarily restores freer breathing through the nose", "Purpose": "• Nasal Congestant", "Directions": " adults and children 12 years and older take 2 tablets every 4 to 6 hours; do not take more than 8 tablets in 24 hours children ages 6 to 12 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", "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 2 weeks after stoppin the MAOI drug. If you do not know if your prescription drug contains and MAOI, ask a doctor or pharmacist before taking this product.", "Other information": "• store at room temperature 15º-30ºC (59º-86ºF)", "Inactive ingredients": "• calcium sulfate, carnauba wax, croscarmellose sodium, FD&C red #40 lake, FD&C yellow #6 lake, gelatin, kaolin, lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, silica, stearic acid, sugar and titanium dioxide", "Questions or comments?": "1-800-645-2158", "Principal Display Panel": "Rugby® compare to Sudafed® Decongestant active ingredient* NDC 63187-344-24 Nasal Decongestant pseudoephedrine HCl 30 mg Temporarily relieves: • nasal congestion due to cold & allergies withoout drowsiness 24 tablets, 30 mg each TAMPER EVIDENT: SAFETY SEALED: DO NOT USE IF BLISTER SEAL IS BROKEN Rev 04/13 R-29 DISTRIBUTED BY: Rugby Laboratories 31778 Enterprise Drive Livonia, MI 48150 Error! Hyperlink reference not valid. Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320", "When using this product": "• do not use more than directed", "Stop use and ask a doctor if": "• nervousness, dizziness, or sleeplessness occur • symptoms do not improve within 7 days or occur with 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": "• diabetes • high blood pressure • heart disease • thyroid disease • trouble urinating due to an enlarged prostate gland"}