PSEUDO TIME PE- phenylephrine hchloride tablet, film coated 
TIME CAP LABORATORIES, INC.

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.

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49483-234 pseudo time pe

Each tablet contains: Phenylephrine HCl 10 mg

INACTIVE INGREDIENTS: CARNAUBA WAX, CROSCARMELLOSE SODIUM, DIBASIC CALCIUM PHOSPHATE DIHYDRATE, FD-C RED#40 ALUMINUM LAKE, FD-C YELLOW#6 ALUMINUM LAKE, HYPROMELLOSE, MAGNESIUM STEARATE, MICROCRYSTALLINE CELLULOSE, POLYETHYLENE GLYCOL (PEG) 400, STEARIC ACID, TITANIUM DIOXIDE

keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

PURPOSE: nasal decongestant

Uses:

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

DIRECTIONS:

Take every 4 hours; Do not take more than 6 doses in 24 hours; Adults and children 12 years of age and over; 1 tablet

Children under 12 years of age; ask a doctor


WARNINGS;

Do not use if you are 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.

234label

PSEUDO TIME PE 
phenylephrine hchloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-234
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorredScoreno score
ShapeROUNDSize7mm
FlavorImprint Code T234
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49483-234-1818 in 1 BLISTER PACK; Type 0: Not a Combination Product12/14/2018
2NDC:49483-234-3636 in 1 BLISTER PACK; Type 0: Not a Combination Product12/14/2018
3NDC:49483-234-00100000 in 1 CARTON; Type 0: Not a Combination Product12/14/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/14/2012
Labeler - TIME CAP LABORATORIES, INC. (037052099)
Establishment
NameAddressID/FEIBusiness Operations
TIME CAP LABORATORIES, INC037052099manufacture(49483-234)

Revised: 12/2018
Document Id: 7d0279a6-3a55-e7e4-e053-2a91aa0a1df7
Set id: 3116f273-0517-4755-95cd-be3a7c0dd76b
Version: 2
Effective Time: 20181214
 
TIME CAP LABORATORIES, INC.