Package Insert and Label Information: Pseudoephedrine Non Drowsy Formula
PSEUDOEPHEDRINE NON DROWSY FORMULA- pseudoephedrine hydrochloride tablet
Contract Pharmacal Corp
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Facts
Active Ingredient
(in each tablet)
Pseudoephedrine Hydrochloride 30 mg
Purposes
Nasal Decongestant
Uses
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- temporarily relieves sinus congestion and pressure
Warnings
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 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.
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to enlargement of the prostate gland
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occurs
- symptoms do not improve within 7 days or occur with a 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 Poison Control Center right away. (1-800-222-1222)
Directions
| adults and children 12 years of age and over |
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| children 6 to 12 years of age |
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| children under 6 years of age | do not use this product in children under 6 years of age |
DO NOT EXCEED RECOMMENDED DOSE
Other information
- store at room temperature, USP
- side effects occur. You may report side effects to the FDA at 1-800-FDA-1088 (Toll Free).
Inactive Ingredients
Calcium Sulfate, Carnauba Wax, Croscarmellose Sodium, D&C Red #40 Lake, FD&C Yellow #6 Lake, Gelatin, Kaolin, Lactose, Magnesium Silicate, Microcrystalline Cellulose, Pharmaceutical Glaze, Silica, Stearic Acid, Sugar and Titanium Dioxide
*This product is not manufactured or distributed by McNEIL-PPC, Inc., owner of the registered trademark Sudafed® Congestion.
Manufactured by:
Contract Pharmacal Corp.,
135 Adams Ave
Hauppauge, NY 11788 USA
www.CPCHealth.com
R 09/10
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
| PSEUDOEPHEDRINE
NON DROWSY FORMULA pseudoephedrine hydrochloride tablet | ||||||||||||||||||||||||||||||||||||
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| Labeler — Contract Pharmacal Corp (968334974) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Contract Pharmacal Corp | 968334974 | MANUFACTURE | |
Revised: 01/2012 Contract Pharmacal Corp
