Sinus Congestion PE by AMERIFOODS TRADING COMPANY 1131-FIR-2023-1102

Sinus Congestion PE by

Drug Labeling and Warnings

Sinus Congestion PE by is a Otc medication manufactured, distributed, or labeled by AMERIFOODS TRADING COMPANY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SINUS CONGESTION PE- phenylephrine hydrochloride tablet, coated 
AMERIFOODS TRADING COMPANY

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1131-FIR-2023-1102

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 useif 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

Questions or comments?

1-844-705-4384

PRINCIPAL DISPLAY PANEL

First Street®

NDC: 61504-131-03

†COMPARE TO THE ACTIVE INGREDIENT IN SUDAFED PE® SINUS CONGESTION

MAXIMUM STRENGTH

Sinus Congestion PE

Phenylephine HCl Tablets

Nasal Decongestant

For Relief of:

Sinus Pressure

Sinus Congestion

NON-DROWSY

ACTUAL SIZE

36 TABLETS 10 mg EACH

SINUS CONGESTION PE 
phenylephrine hydrochloride tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61504-131
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
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)
HYPROMELLOSES (UNII: 3NXW29V3WO)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61504-131-03	2 in 1 CARTON	10/30/2023	10/30/2023
1		18 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	10/30/2023	10/30/2023

Labeler - AMERIFOODS TRADING COMPANY (626388680)

Revised: 12/2024

Document Id: 287331bf-6dbf-4c2e-e063-6394a90ab7b6

34390-5

Set id: f6ce5f7f-8115-f6cb-e053-6394a90a1f82

Version: 3

Effective Time: 20241204