FDA Label for Loratadine And Pseudoephedrine Sulfate
View Indications, Usage & Precautions
Loratadine And Pseudoephedrine Sulfate Product Label
The following document was submitted to the FDA by the labeler of this product Wal-mart Stores, Inc. 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: Walmart Inc., Bentonville, AR 72716
Otc - Purpose
| Active ingredients (in each tablet) | Purpose |
|---|---|
| Loratadine, USP 10 mg | Antihistamine |
| Pseudoephedrine sulfate, USP 240 mg | Nasal decongestant |
Uses
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- sneezing
- itchy, watery eyes
- runny nose
- itching of the nose or throat
- reduces swelling of nasal passages
- temporarily relieves sinus congestion and pressure
- 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 have ever had an allergic reaction to this product or any of its ingredients
- 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
- thyroid disease
- high blood pressure
- diabetes
- trouble urinating due to an enlarged prostate gland
- liver or kidney disease. Your doctor should determine if you need a different dose.
Otc - When Using
When using this product do not take more than directed. Taking more than directed may cause drowsiness.
Stop Use And Ask A Doctor If
- an allergic reaction to this product occurs. Seek medical help right away.
- symptoms do not improve within 7 days or are accompanied by a fever
- nervousness, dizziness or sleeplessness occurs
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
- do not divide, crush, chew or dissolve the tablet
| adults and children 12 years and over | 1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours |
| children under 12 years of age | ask a doctor |
| consumers with liver or kidney disease | ask a doctor |
Other Information
- sodium: contains 10 mg/tablet
- calcium: contains 25 mg/tablet
- TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
- store between 20° C to 25° C (68° F to 77° F).
- protect from light and store in a dry place
Inactive Ingredients
calcium carbonate, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, sodium alginate, sodium citrate, talc and titanium dioxide
Questions?
call 1-800-406-7984
Principal Display Panel - 15 Tablet Bottle Carton
equate™
NON-DROWSY*
Allergy Relief &
Nasal Decongestant
Loratadine, USP 10mg/Antihistamine
Pseudoephedrine Sulfate,
USP 240mg/Nasal Decongestant
INDOOR AND OUTDOOR ALLERGIES
24 Hour Relief of:
- Nasal & sinus congestion due to colds or allergies
- Sneezing • Runny nose • Itchy, watery eyes
- Itchy throat or nose due to allergies
Original prescription strength
*When taken as directed. See Drug Facts Panel.
NDC 49035-488-15
Compare to
Claritin-D® 24Hr
active ingredients**
24
HOUR
Actual Size
15
EXTENDED-
RELEASE
TABLETS
* Please review the disclaimer below.