Ed Chlorped Jr.

Ed Chlorped Jr.
SPL v9
SPL
SPL Set ID 4a5e5968-1930-465a-9b8c-45ed936a0e11
Route
ORAL
Published
Effective Date 2020-03-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorpheniramine (2 mg)
Inactive Ingredients
Citric Acid Monohydrate Fd&c Red No. 40 Methylparaben Potassium Citrate Potassium Sorbate Propylparaben Propylene Glycol Water Sorbitol Sucralose

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2011-03-04 Until 2019-09-16

Description

Drug Facts

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

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

Section 50569-3

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

Section 53414-9

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

Warnings

Do not exceed recommended dosage.

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].

Active Ingredients

Chlorpheniramine Maleate 2 mg

Question? Comments?

Call 1-800-543-9560

Inactive Ingredients

Cherry Flavor, Citric Acid, FD&C Red # 40, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sorbitol Solution 70%, Sucralose.

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
Principal Display Panel 473 Ml Bottle Label

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.

Paoli, PA 19301

16oz. (473 mL)

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

Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50569-3 (50569-3)

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

Section 53414-9 (53414-9)

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

Purpose

Antihistamine

Warnings

Do not exceed recommended dosage.

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 (Other information)

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

Active Ingredients

Chlorpheniramine Maleate 2 mg

Question? Comments?

Call 1-800-543-9560

Inactive Ingredients (Inactive ingredients)

Cherry Flavor, Citric Acid, FD&C Red # 40, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sorbitol Solution 70%, Sucralose.

When Using This Product (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
Principal Display Panel 473 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label)

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.

Paoli, PA 19301

16oz. (473 mL)

Do Not Take This Product, Unless Directed By A Doctor, If You Have (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

Advanced Ingredient Data


Raw Label Data

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