LORATADINE AND PSEUDOEPHEDRINE- loratadine and pseudoephedrine sulfate tablet, extended release 
Bryant Ranch Prepack

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DRUG FACTS

ACTIVE INGREDIENTS (IN EACH TABLET)

Loratadine, USP 10 mg

Pseudoephedrine sulfate, USP 240 mg

PURPOSE

Antihistamine

Nasal decongestant

USES

WARNINGS

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.

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

If pregnant or breast-feeding,

ask a health professional before use.

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

OTHER INFORMATION

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

Loratadine/psuedoephedrine 24 Hour tab

Label
LORATADINE AND PSEUDOEPHEDRINE 
loratadine and pseudoephedrine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-1330(NDC:51660-724)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE 10 mg
PSEUDOEPHEDRINE SULFATE (UNII: Y9DL7QPE6B) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE SULFATE 240 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONES (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM ALGINATE (UNII: C269C4G2ZQ)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color white Score no score
Shape CAPSULE Size 17mm
Flavor Imprint Code RX724
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63629-1330-1 14 in 1 BOTTLE
2 NDC:63629-1330-2 5 in 1 BOTTLE
3 NDC:63629-1330-3 10 in 1 BOTTLE
4 NDC:63629-1330-4 15 in 1 BOTTLE
5 NDC:63629-1330-5 30 in 1 BOTTLE
6 NDC:63629-1330-6 60 in 1 BOTTLE
7 NDC:63629-1330-7 20 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076557 11/17/2004
Labeler - Bryant Ranch Prepack (171714327)
Registrant - Bryant Ranch Prepack (171714327)
Establishment
Name Address ID/FEI Business Operations
Bryant Ranch Prepack 171714327 REPACK(63629-1330) , RELABEL(63629-1330)

Revised: 1/2013
Document Id: 49422e04-2bc1-46b6-8198-aa37a195d818
Set id: 37e1393b-7176-4480-9299-5bb9db62e19e
Version: 1000
Effective Time: 20130118
 
Bryant Ranch Prepack