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NDC 49483-0234-36 PSEUDO TIME PE 10 mg/1 Details

PSEUDO TIME PE 10 mg/1

PSEUDO TIME PE is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by TIME CAP LABORATORIES, INC.. The primary component is PHENYLEPHRINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.

Related Packages: 49483-0234-36
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	49483-0234
Product ID	49483-234_7d0279a6-3a55-e7e4-e053-2a91aa0a1df7
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	PSEUDO TIME PE
Proprietary Name Suffix	n/a
Non-Proprietary Name	PHENYLEPHRINE HCHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	10
Active Ingredient Units	mg/1
Substance Name	PHENYLEPHRINE HYDROCHLORIDE
Labeler Name	TIME CAP LABORATORIES, INC.
Pharmaceutical Class	Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 49483-0234-36 (49483023436)

Pricing Information	N/A
NDC Package Code	49483-234-36
Billing NDC	49483023436
Package	36 TABLET, FILM COATED in 1 BLISTER PACK (49483-234-36)
Marketing Start Date	2018-12-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3116f273-0517-4755-95cd-be3a7c0dd76b Details

SPL UNCLASSIFIED SECTION

Each tablet contains: Phenylephrine HCl 10 mg

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

PURPOSE: nasal decongestant

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	05/14/2012

Labeler - TIME CAP LABORATORIES, INC. (037052099)

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

Revised: 12/2018

Document Id: 7d0279a6-3a55-e7e4-e053-2a91aa0a1df7

Set id: 3116f273-0517-4755-95cd-be3a7c0dd76b

Version: 2

Effective Time: 20181214

Search by Drug Name or NDC

NDC 49483-0234-36 PSEUDO TIME PE 10 mg/1 Details

PSEUDO TIME PE 10 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 49483-0234-36 (49483023436)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 3116f273-0517-4755-95cd-be3a7c0dd76b Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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