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Drug Facts
Distributed by: Rugby Laboratories
17177 N Laurel Park Drive, Suite 233,
Livonia, MI, 48152
Rugby
FDA Label NDC 50090-0226
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by A-s Medication Solutions for the product Rugby (NDC 50090-0226). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (in each teaspoonful), purpose, uses, warnings, stop use and ask a doctor if, ask a doctor before use if you have, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Teaspoonful)
Pseudoephedrine HCl 30 mg
Purpose
Nasal decongestant
Uses
temporarily relieves nasal congestion due to
- common cold
- hay fever or other respiratory allergies
Warnings
Do not exceed recommended dosage.
Stop Use And Ask A Doctor If
- you get nervous, dizzy or sleepless
- symptoms do not get better within 7 days or occur with fever
Ask A Doctor Before Use If You Have
- diabetes
- heart disease
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
Otc - Do Not Use
Do not use if you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkison'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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - 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.
Directions
- take every 4 - 6 hours
- do not take more than 4 doses in 24 hours
- use enclosed dosage cup only. Do not use any other device.
| adults & children 12 years & over | 2 teaspoonfuls |
| children 6 to under 12 years | 1 teaspoonful |
| children under 6 years | do not use |
Other Information
- store at 20°-25°C (68°-77°F).
- protect from light
Inactive Ingredients
artificial raspberry flavor, citric acid, FD&C red #40, glycerin, methylparaben, purified water, saccharin sodium, sodium benzoate, sorbitol solution
Questions Or Comments?
1-800-645-2158
How Supplied
Product: 50090-0226
NDC: 50090-0226-0 118 mL in a BOTTLE
* Please review the disclaimer below.
