PSEUDO-TIME

Dosage form: tablet, coated
Ingredients: PSEUDOEPHEDRINE HYDROCHLORIDE 30mg
Labeler: TIME CAP LABORATORIES, INC.
NDC Code: 49483-016

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

In each tablet Pseudoephedrine HCl 30 mg


  Nasal Decongestant

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away

INDICATIONS AND USAGE:

Temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, and nasal congestion associated with sinusitis

Temporarily relieves sinus congestion and pressure



WARNINGS: Do not use 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.

DOSAGE AND ADMINISTRATION:

Directions – take every 4-6 hours -Do not take more than 4 does in 24 hours

Adults and children 12 years and over – 2 tablets

Children 6 to under 12 years – 1 tablet

Children under 6 years – ask a doctor

INACTIVE INGREDIENTS:  acacia, calcium sulfate, carnauba Wax. colloidal silicon dioxide, corn starch, D-C red no. 27, D-C yellow no.10, FD-C red no.40, FD-C yellow  no 6, iron oxide black, iron oxide red, iron oxide yellow (iron oxide ochre) Kaolin, microcrystalline cellulose, polyethylene glycol (PEG) 400, , pregelatinized starch, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide

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PSEUDO-TIME  
pseudoephedrine hcl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-016
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE ) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA  
CALCIUM SULFATE ANHYDROUS  
CARNAUBA WAX 
SILICON DIOXIDE  
STARCH, CORN  
D&C RED NO. 27  
D&C YELLOW NO. 10  
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
FERROSOFERRIC OXIDE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
KAOLIN 
CELLULOSE, MICROCRYSTALLINE  
POLYETHYLENE GLYCOL 400 
POLYETHYLENE GLYCOL 400 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
SUCROSE 
TALC 
TITANIUM DIOXIDE  
Product Characteristics
ColorredScoreno score
ShapeROUNDSize6mm
FlavorImprint CodeTCL016
Contains    
Packaging
#Item CodePackage Description
1NDC:49483-016-9696 TABLET, COATED (TABLET) in 1 BLISTER PACK
2NDC:49483-016-2424 TABLET, COATED (TABLET) in 1 BLISTER PACK
3NDC:49483-016-4848 TABLET, COATED (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/01/2012
Labeler - TIME CAP LABORATORIES, INC. (037052099)
Establishment
NameAddressID/FEIOperations
TIME CAP LABORATORIES, INC.037052099manufacture(49483-016)

Revised: 07/2012
 
TIME CAP LABORATORIES, INC.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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