Active Ingredient (In Each Tablet)
- Pseudoephedrine HCl 30 mg
Nasal Decongestant Tablet
FDA Label NDC 63187-344
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Proficient Rx Lp for the product Nasal Decongestant (NDC 63187-344). 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 active ingredient (in each tablet), purpose, use(s), do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
- Nasal Congestant
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
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.
Ask A Doctor Before Use If You Have
- diabetes
- high blood pressure
- heart disease
- thyroid disease
- trouble urinating due to an enlarged prostate gland
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).
Directions
adults and children | take 2 tablets every 4 to 6 hours; |
children ages 6 to 12 years | take 1 tablet every 4 to 6 hours; |
children under 6 years | do not use |
Other Information
- store at room temperature 15°-30°C (59°-86°F)
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
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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
www.rugbylaboratories.com
Repackaged by:
Proficient Rx LP
Thousand Oaks, CA 91320
Pseudoephedrine 30mg (Nasal Decongestant Pseudoephdrine HCl 30 mg Tablet 1)
* Please review the disclaimer below.
