FDA Label for Nasal Decongestant
View Indications, Usage & Precautions
- 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,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Nasal Decongestant Product Label
The following document was submitted to the FDA by the labeler of this product Proficient Rx Lp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Tablet)
• Pseudoephedrine HCl 30 mg
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
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
www.rugbylaboratories.com
Repackaged by:
Proficient Rx LP
Thousand Oaks, CA 91320
* Please review the disclaimer below.