FDA Label for Pseudoephedrine Hydrochloride
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- OTC - DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- OTC - WHEN USING
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - 120 MG BLISTER PACK CARTON
Pseudoephedrine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product The Kroger Company. 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.
Other
Drug Facts
DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OH 45202
Active Ingredient (In Each Tablet)
Pseudoephedrine HCl, USP 120 mg
Purpose
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
Otc - 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 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 an enlarged prostate gland
Otc - When Using
When using this product do not exceed recommended dosage
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- symptoms do not improve within 7 days or occur with a fever
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. (1-800-222-1222)
Directions
adults and children 12 years and over |
|
children under 12 years | do not use this product in children under 12 years of age |
Other Information
- store at 59° to 77° F in a dry place. Protect from light
- TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
Inactive Ingredients
castor oil, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, magnesium stearate, titanium dioxide
Questions?
1-800-632-6900
Principal Display Panel - 120 Mg Blister Pack Carton
COMPARE TO the active ingredient of
SUDAFED® 12 HOUR **See side panel
NDC 30142-967-20
Kroger®
OUR PHARMACIST RECOMMENDED
Maximum Strength
Sinus
Pseudoephedrine Hydrochloride 120 mg
12 Hour Extended-Release Tablets, USP
LONG ACTING
NASAL DECONGESTANT
NON-DROWSY
Relieves Sinus
Pressure + Congestion
actual
size
12
HOUR
20 COATED
CAPLETS*
120 mg EACH
*capsule-shaped tablets
* Please review the disclaimer below.