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NDC 46122-0181-62 Cold and Allergy 4; 10 mg/1; mg/1 Details

Cold and Allergy 4; 10 mg/1; mg/1

Cold and Allergy is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by AmerisourceBergen (Good Neighbor Pharmacy) 46122. 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: 46122-0181-62
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: 46122-0181-62
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	46122-0181
Product ID	46122-181_6b59f4da-6875-4edb-9264-41573a1e251e
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	Cold and Allergy
Proprietary Name Suffix	Maximum Strength
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	AmerisourceBergen (Good Neighbor Pharmacy) 46122
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	n/a

Package

Package Images

NDC 46122-0181-62 (46122018162)

Pricing Information	N/A
NDC Package Code	46122-181-62
Billing NDC	46122018162
Package	1 BLISTER PACK in 1 CARTON (46122-181-62) / 24 TABLET in 1 BLISTER PACK
Marketing Start Date	2011-04-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7b3de930-7c5f-4eef-a74b-902dffcb8cb4 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:
- runny nose
- sneezing
- itchy, watery eyes
- nasal congestion
- itching of the nose or throat
temporarily relieves these symptoms due to the common cold:
- runny nose
- sneezing
- nasal congestion

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
glaucoma
diabetes
trouble urinating due to an enlarged prostate gland
thyroid disease
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 use more than directed
drowsiness may occur
avoid alcoholic drinks
excitability may occur, especially in children
alcohol, sedatives and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

you get nervous, dizzy, or sleepless
symptoms do not get better within 7 days or are accompanied by a fever

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

take every 4 hours
do not take more than 6 doses in 24 hours

adults and children 12 years of age and older	take 1 tablet
children 6 to under 12 years of age	take 1/2 tablet
children under 6 years of age	consult a doctor
children under 4 years of age	do not use

Other information

store at 15º-30ºC (59º-86ºF)

Inactive ingredients

colloidal silicon dioxide, dicalcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, pregelatinized corn starch, sodium starch glycolate and stearic acid

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

*Compare to Maximum Strength Actifed® Cold & Allergy active ingredients

Does not contain Pseudoephedrine

Maximum Strength Cold & Allergy

chlorpheniramine maleate 4 mg & phenylephrine HCl 10 mg

Antihistamine / Nasal Decongestant

Runny Nose
Sneezing
Itchy, Watery Eyes
Nasal Congestion

tablets / one table dose

*This product is not manufactured or distributed by McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., owner of the registered trademark Actifed® Cold & Allergy

TAMPER EVIDENT- USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed By AmerisourceBergen

1300 Morris Drive, Chesterbrook, PA 19087

Visit us at www.mygnp.com

Product Label

Chlorpheniramine Maleate 4 mg, Phenylephrine HCI 10 mg

Good Neighbor Pharmacy Maximum Strength Cold & Allergy

INGREDIENTS AND APPEARANCE

COLD AND ALLERGY MAXIMUM STRENGTH

chlorpheniramine maleate, phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:46122-181
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	7mm
Flavor		Imprint Code	T127
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:46122-181-62	1 in 1 CARTON	04/02/2011	01/05/2024
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	04/02/2011	01/05/2024

Labeler - AmerisourceBergen (Good Neighbor Pharmacy) 46122 (007914906)

Revised: 10/2021

Document Id: 6b59f4da-6875-4edb-9264-41573a1e251e

Set id: 7b3de930-7c5f-4eef-a74b-902dffcb8cb4

Version: 4

Effective Time: 20211015