1004 - Rugby

1004 - Rugby
SPL v5
SPL
SPL Set ID 775f97c0-6f82-49a8-82ac-f1a73920c3ec
Route
ORAL
Published
Effective Date 2022-12-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pseudoephedrine (30 mg)
Inactive Ingredients
Croscarmellose Sodium Fd&c Yellow No. 6 Magnesium Stearate Cellulose, Microcrystalline Titanium Dioxide Calcium Cation Carnauba Wax Fd&c Red No. 40 Gelatin Kaolin Anhydrous Lactose Talc Shellac Silicon Dioxide Stearic Acid Sucrose Starch, Corn

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

Description

Active ingredient (in each tablet) Pseudoephedrine HCl 30 mg

Purpose

Nasal decongestant


Medication Information

Purpose

Nasal decongestant

Description

Active ingredient (in each tablet) Pseudoephedrine HCl 30 mg

Uses
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • temporarily restores freer breathing through the nose
Section 42229-5

*Rugby Laboratories is not affiliated with the owner of the registered trademark Sudafed®

SAFETY SEALED: DO NOT USE IF BLISTER SEAL IS BROKEN

Distributed by:

RUGBY® LABORATORIES

Indianapolis, IN 46268

www.majorpharmaceuticals.com

Re-order No. 370277

Rev. 08/22 R-29

Section 51945-4

Rugby®

Compare to active ingredient in Sudafed® Sinus Congestion*

NDC 0536-3607-35

Nasal D econgestant

Pseudoephedrine HCl 30 mg

Temporarily relieves nasal congestion due to colds & allergies without drowsiness

24 tablets

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 stopping the MAOI drug. If you do not know if your prescription drug contains and MAOI, ask a doctor or pharmacist before taking this product.
Drug Facts

Active ingredient (in each tablet)

Pseudoephedrine HCl 30 mg

Other Information
  • Store in a dry place at 15° – 30°C (59° – 86°F).
Inactive Ingredients

calcium sulfate, carnauba wax, corn starch, croscarmellose sodium, FD&C red #40 lake, FD&C yellow #6 lake, gelatin, kaolin, lactose monohydrate, magnesium stearate, microcrystalline cellulose, shellac, silicon dioxide, stearic acid, sucrose, talc, titanium dioxide.

Questions Or Comments?

1-800-616-2471

When Using This Product
  • do not exceed recommended dose
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).
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 restores freer breathing through the nose
Section 42229-5 (42229-5)

*Rugby Laboratories is not affiliated with the owner of the registered trademark Sudafed®

SAFETY SEALED: DO NOT USE IF BLISTER SEAL IS BROKEN

Distributed by:

RUGBY® LABORATORIES

Indianapolis, IN 46268

www.majorpharmaceuticals.com

Re-order No. 370277

Rev. 08/22 R-29

Section 51945-4 (51945-4)

Rugby®

Compare to active ingredient in Sudafed® Sinus Congestion*

NDC 0536-3607-35

Nasal D econgestant

Pseudoephedrine HCl 30 mg

Temporarily relieves nasal congestion due to colds & allergies without drowsiness

24 tablets

Purpose

Nasal decongestant

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 stopping the MAOI drug. If you do not know if your prescription drug contains and MAOI, ask a doctor or pharmacist before taking this product.
Drug Facts

Active ingredient (in each tablet)

Pseudoephedrine HCl 30 mg

Other Information (Other information)
  • Store in a dry place at 15° – 30°C (59° – 86°F).
Inactive Ingredients (Inactive ingredients)

calcium sulfate, carnauba wax, corn starch, croscarmellose sodium, FD&C red #40 lake, FD&C yellow #6 lake, gelatin, kaolin, lactose monohydrate, magnesium stearate, microcrystalline cellulose, shellac, silicon dioxide, stearic acid, sucrose, talc, titanium dioxide.

Questions Or Comments? (Questions or comments?)

1-800-616-2471

When Using This Product (When using this product)
  • do not exceed recommended dose
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).
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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