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NDC 46122-0597-62 Sinus and Allergy Relief 4; 10 mg/1; mg/1 Details

Sinus and Allergy Relief 4; 10 mg/1; mg/1

Sinus and Allergy Relief is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Amerisource Bergen. The primary component is CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Chlorpheniramine relieves red, itchy, watery eyes; sneezing; itchy nose or throat; and runny nose caused by allergies, hay fever, and the common cold. Chlorpheniramine helps control the symptoms of cold or allergies but will not treat the cause of the symptoms or speed recovery. Chlorpheniramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 46122-0597-62
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Chlorpheniramine

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: 46122-0597-62
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	46122-0597
Product ID	46122-597_ffef229c-25e1-4109-8ea5-5ec2433eae8e
Associated GPIs	43993002300315
GCN Sequence Number	059701
GCN Sequence Number Description	chlorpheniramine/phenylephrine TABLET 4MG-10MG ORAL
HIC3	Z2N
HIC3 Description	1ST GEN ANTIHISTAMINE AND DECONGESTANT COMBINATION
GCN	25462
HICL Sequence Number	000446
HICL Sequence Number Description	CHLORPHENIRAMINE MALEATE/PHENYLEPHRINE HCL
Brand/Generic	Generic
Proprietary Name	Sinus and Allergy Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Chlorpheniramine maleate, Phenylephrine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	4; 10
Active Ingredient Units	mg/1; mg/1
Substance Name	CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Labeler Name	Amerisource Bergen
Pharmaceutical Class	Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2023-12-31

Package

Package Images

NDC 46122-0597-62 (46122059762)

Pricing Information	N/A
NDC Package Code	46122-597-62
Billing NDC	46122059762
Package	1 BLISTER PACK in 1 CARTON (46122-597-62) / 24 TABLET in 1 BLISTER PACK
Marketing Start Date	2019-05-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 423ef008-29c7-4184-8899-fa71f86a1d80 Details

Active ingredients (in each tablet)

Chlorpheniramine maleate 4 mg

Phenylephrine HCl 10 mg

Purpose

Antihistamine

Nasal decongestant

Uses

temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
- itchy, watery eyes
- runny nose
- itching of the nose or throat
- nasal congestion
- sneezing
- sinus congestion and pressure

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

high blood pressure
heart disease
thyroid disease
diabetes
glaucoma
difficulty in urination due to enlargement of the prostate gland
a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

do not exceed recommended dosage
excitability may occur, especially in children
drowsiness may occur
avoid alcoholic beverages
alcohol, sedatives and tranquilizers may increase drowsiness
use caution when driving a motor vehicle or operating machinery

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 (1-800-222-1222) right away.

Directions

adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
children under 12 years: do not use

Other information

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
see end flap for expiration date and lot number

Inactive ingredients

croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

Questions or comments?

1-800-426-9391

Principal display panel

NDC 46122-597-62

Good

Neighbor

Pharmacy®

MAXIMUM STRENGTH

Sinus + Allergy

Relief PE

Chlorpheniramine maleate 4 mg

Phenylephrine HCl 10 mg

Antihistamine, Nasal Decongestant

Relief of:

• Sneezing, Itchy Eyes & Runny Nose

• Sinus Pressure & Congestion

24 Tablets

Actual Size

50844 ORG031946208

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Distributed By

AmerisourceBergen

1300 Morris Drive

Chesterbrook, PA 19087

Questions or Concerns?

www.mygnp.com

GNP 44-462

INGREDIENTS AND APPEARANCE

SINUS AND ALLERGY RELIEF

chlorpheniramine maleate, phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:46122-597
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	44;462
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:46122-597-62	1 in 1 CARTON	05/30/2019
1		24 in 1 BLISTER PACK; 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	05/30/2019

Labeler - Amerisource Bergen (007914906)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(46122-597)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(46122-597)

Revised: 4/2022

Document Id: ffef229c-25e1-4109-8ea5-5ec2433eae8e

Set id: 423ef008-29c7-4184-8899-fa71f86a1d80

Version: 4

Effective Time: 20220422