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NDC 00485-0098-16 ED CHLORPED JR 2 mg/5mL Details

ED CHLORPED JR 2 mg/5mL

ED CHLORPED JR is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by EDWARDS PHARMACEUTICALS, INC.. The primary component is CHLORPHENIRAMINE MALEATE.

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: 00485-0098-16
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Chlorpheniramine

Product Information

NDC	00485-0098
Product ID	0485-0098_6517148a-7c82-4eda-b728-6e1e86a982b9
Associated GPIs	41100020151205
GCN Sequence Number	011639
GCN Sequence Number Description	chlorpheniramine maleate SYRUP 2 MG/5 ML ORAL
HIC3	Z2P
HIC3 Description	ANTIHISTAMINES - 1ST GENERATION
GCN	46503
HICL Sequence Number	004505
HICL Sequence Number Description	CHLORPHENIRAMINE MALEATE
Brand/Generic	Generic
Proprietary Name	ED CHLORPED JR
Proprietary Name Suffix	n/a
Non-Proprietary Name	CHLORPHENIRAMINE MALEATE
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	2
Active Ingredient Units	mg/5mL
Substance Name	CHLORPHENIRAMINE MALEATE
Labeler Name	EDWARDS PHARMACEUTICALS, INC.
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2023-12-31

Package

Package Images

NDC 00485-0098-16 (00485009816)

Pricing Information	N/A
NDC Package Code	0485-0098-16
Billing NDC	00485009816
Package	473 mL in 1 BOTTLE, PLASTIC (0485-0098-16)
Marketing Start Date	2011-03-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4a5e5968-1930-465a-9b8c-45ed936a0e11 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients (in each 5 mL teaspoonful)

Chlorpheniramine Maleate 2 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other respiratory allergies:

runny nose
sneezing
itching of the nose or throat
itchy, watery eyes

Warnings

Do not exceed recommended dosage.

Do not take this product, unless directed by a doctor, if you have

a breathing problem such as emphysema or chronic bronchitis
glaucoma
difficulty in urination due to enlargement of the prostate gland

Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.

When using this product

excitability may occur, especially in children
may cause marked drowsiness
sedatives and tranquilizers may increase drowsiness effect
avoid alcoholic beverages
use caution when driving a motor vehicle or operating machinery

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Directions

Do not exceed recommended dosage.

Adults and children 12 years of age and over:	2 teaspoonfuls (10 mL) every 4 to 6 hours, not to exceed 12 teaspoonfuls in 24 hours, or as directed by a doctor.
Children 6 to under 12 years of age:	1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls in 24 hours, or as directed by a doctor.
Children under 6 years of age:	Consult a doctor

Other information

Store at 59° - 86° F (15° - 30° C) [see USP for Controlled Room Temperature].

Inactive ingredients

Artificial and Natural Cherry Flavor, Citric Acid, FD&C Red # 40, Glycerin, Methyl Paraben, Propylene Glycol, Propylparaben, Purified Water, Sodium Citrate, Sucralose.

Question? Comments?

Call 1-800-543-9560

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

ED Chlorped Jr.

NDC 0485-0098-16

ED Chlorped Jr.

ANTIHISTAMINE

FOR PROFESSIONAL USE ONLY

Sugar Free • Alcohol Free

Each teaspoonful (5 mL)

for oral administration contains:

Chlorpheniramine Maleate 2 mg

Cherry Flavor

Tamper evident by foil seal under cap.

Do not use if foil seal is broken or

missing.

Manufactured for:

EDWARDS

Pharmaceuticals, Inc.

Ripley, MS 38663

16oz. (473 mL)

INGREDIENTS AND APPEARANCE

ED CHLORPED JR

chlorpheniramine maleate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0485-0098
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
METHYLPARABEN (UNII: A2I8C7HI9T)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0485-0098-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/04/2011
2	NDC:0485-0098-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/04/2011	09/16/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	03/04/2011

Labeler - EDWARDS PHARMACEUTICALS, INC. (195118880)

Revised: 10/2022

Document Id: 6517148a-7c82-4eda-b728-6e1e86a982b9

Set id: 4a5e5968-1930-465a-9b8c-45ed936a0e11

Version: 6

Effective Time: 20221010