Label: LORATADINE D- loratadine and pseudoephedrine sulfate tablet, extended release
- NDC Code(s): 63629-4790-1
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 45802-106
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
If you are a consumer or patient please visit this version.
- Active ingredients (in each tablet)
Loratadine 5 mg
Pseudoephedrine sulfate 120 mgClose
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- 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
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
- trouble urinating due to an enlarged prostate gland
- liver or kidney disease. Your doctor should determine if you need a different dose.
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
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)
- 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
ask a doctor
- Other information
- each tablet contains: calcium 25 mg
- do not use if blister unit is broken 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 stearate, pharmaceutical ink, povidone, titanium dioxideClose
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
Pseudoephedrine/Loratadine 120mg/ 5mgClose
- INGREDIENTS AND APPEARANCE
loratadine, pseudoephedrine tablet, extended release
Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:63629-4790(NDC:45802-106) Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LORATADINE (LORATADINE) LORATADINE 5 mg PSEUDOEPHEDRINE SULFATE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE SULFATE 120 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONES TITANIUM DIOXIDE Product Characteristics Color WHITE Score no score Shape ROUND Size 12mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63629-4790-1 14 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076050 01/19/2012 Labeler - Bryant Ranch Prepack (171714327) Registrant - Bryant Ranch Prepack (171714327) Establishment Name Address ID/FEI Business Operations Bryant Ranch Prepack 171714327 REPACK(63629-4790), RELABEL(63629-4790)