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NDC 36800-0331-05 Congestion PE 10 mg/1 Details

Congestion PE 10 mg/1

Congestion PE is a ORAL TABLET, COATED in the HUMAN OTC DRUG category. It is labeled and distributed by TopCo Associates LLC. 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: 36800-0331-05
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	36800-0331
Product ID	36800-331_d15609c1-af38-5dd3-e053-2995a90a4b0c
Associated GPIs	97350000000000
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	Congestion PE
Proprietary Name Suffix	n/a
Non-Proprietary Name	PHENYLEPHRINE HYDROCHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, COATED
Route	ORAL
Active Ingredient Strength	10
Active Ingredient Units	mg/1
Substance Name	PHENYLEPHRINE HYDROCHLORIDE
Labeler Name	TopCo Associates LLC
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	n/a

Package

Package Images

NDC 36800-0331-05 (36800033105)

Pricing Information	N/A
NDC Package Code	36800-331-05
Billing NDC	36800033105
Package	1 BOTTLE, PLASTIC in 1 CARTON (36800-331-05) / 150 TABLET, COATED in 1 BOTTLE, PLASTIC
Marketing Start Date	2011-08-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 75906d1f-930c-4b5c-b188-807c76c2d91a Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Phenylephrine HCl 10 mg

Purpose

Nasal decongestant

Uses

temporarily relieves sinus congestion and pressure
temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

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.

Ask a doctor before use if you have

heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland

When using this product

do not exceed recommended dosage

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur
symptoms do not improve within 7 days or occur with a fever

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

adults and children 12 years of age and over: take 1 tablet every 4 hours; do not take more than 6 tablets in 24 hours
children under 12 years of age: ask a doctor

Other information

store between 20-25°C (68-77°F) in a dry place
retain carton for complete product information and warnings

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C red #27 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, lactose anhydrous, magnesium stearate, polyethylene glycol, stearic acid, titanium dioxide

PRINCIPAL DISPLAY PANEL

NDC 36800-331-05

TopCare® Health™

Compare to Sudafed PE® Pressure + Pain Active Ingredient*

Non-Drowsy

Congestion PE

Maximum Strength

Phenylephrine HCl 10 mg – Nasal Decongestant

Relief of:

Sinus + Nasal Congestion

Sinus Pressure

Our Pharmacists Recommend

150 Tablets

INGREDIENTS AND APPEARANCE

CONGESTION PE

phenylephrine hydrochloride tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-331
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 27 (UNII: 2LRS185U6K)
ALUMINUM OXIDE (UNII: LMI26O6933)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	A;131
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:36800-331-05	1 in 1 CARTON	08/30/2011	06/30/2023
1		150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	08/30/2011	06/30/2023

Labeler - TopCo Associates LLC (006935977)

Revised: 11/2021

Document Id: d15609c1-af38-5dd3-e053-2995a90a4b0c

Set id: 75906d1f-930c-4b5c-b188-807c76c2d91a

Version: 3

Effective Time: 20211121