FDA Label for Claritin-d 12 Hour
View Indications, Usage & Precautions
Claritin-d 12 Hour Product Label
The following document was submitted to the FDA by the labeler of this product Bayer Healthcare Llc.. 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
Otc - Purpose
| Active ingredient (in each tablet) | Purpose |
|---|---|
| Loratadine 5 mg | Antihistamine |
| Pseudoephedrine sulfate 120 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
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- reduces swelling of nasal passages
- temporarily relieves sinus congestion and pressure
- temporarily restores freer breathing through the nose
Otc - Do Not Use
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.
Otc - Ask Doctor
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.
Otc - Stop Use
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.
Directions
- do not divide, crush, chew or dissolve the tablet
| adults and children 12 years and over | 1 tablet every 12 hours; not more than 2 tablets in 24 hours |
| children under 12 years of age | ask a doctor |
| consumers with liver or kidney disease | ask a doctor |
Other Information
- each tablet contains: calcium 30 mg
- safety sealed: do not use if the individual blister unit imprinted with Claritin-D ® 12 Hour is open or torn
- store between 20° to 25°C (68° to 77°F)
- keep in a dry place
Inactive Ingredients
croscarmellose sodium, dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium sterarate, pharmaceutical ink, povidone, titanium dioxide
Questions Or Comments?
1-800-CLARITIN (1-800-252-7484) or www.claritin.com
Principal Display Panel - Carton
NDC 11523-7162-1
Non-Drowsy*
Claritin-D®
pseudoephedrine sulfate 120 mg/nasal decongestant
loratadine 5 mg/antihistamine
Indoor & Outdoor Allergies
Allergy & Congestion
12
Hour
Relief of:
Nasal & Sinus Congestion
Due to Colds or Allergies
Sneezing; Runny Nose;
Itchy, Watery Eyes;
Itchy Throat or Nose
Due to Allergies
* When taken as directed. See Drug Facts Panel.
10
EXTENDED
RELEASE TABLETS
* Please review the disclaimer below.