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
Updated January 21, 2013
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 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 (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE 5 mg PSEUDOEPHEDRINE SULFATE (UNII: Y9DL7QPE6B) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE SULFATE 120 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONES (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 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)