PSEUDO TIME PE- phenylephrine hchloride tablet, film coated

PSEUDO TIME PE by

Drug Labeling and Warnings

PSEUDO TIME PE by is a Otc medication manufactured, distributed, or labeled by TIME CAP LABORATORIES, INC., TIME CAP LABORATORIES, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Each tablet contains: Phenylephrine HCl 10 mg

INACTIVE INGREDIENT

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 REACH OF CHILDREN

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

PURPOSE

PURPOSE: nasal decongestant

INDICATIONS & USAGE

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

DOSAGE & ADMINISTRATION

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

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PSEUDO TIME PE 
phenylephrine hchloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49483-234
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	red	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	T234
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49483-234-18	18 in 1 BLISTER PACK; Type 0: Not a Combination Product	12/14/2018
2	NDC: 49483-234-36	36 in 1 BLISTER PACK; Type 0: Not a Combination Product	12/14/2018
3	NDC: 49483-234-00	100000 in 1 CARTON; Type 0: Not a Combination Product	12/14/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/14/2012

Labeler - TIME CAP LABORATORIES, INC. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
TIME CAP LABORATORIES, INC		037052099	manufacture(49483-234)