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

Purpose

Antihistamine

Description

Drug Facts


Medication Information

Warnings

Do not exceed recommended dosage.

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
Purpose

Antihistamine

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

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

Description

Drug Facts

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.

Active Ingredients

Chlorpheniramine Maleate 2 mg

Question? Comments?

Call 1-800-543-9560

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

Warnings

Do not exceed recommended dosage.

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
Purpose

Antihistamine

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].

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.

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.

Active Ingredients

Chlorpheniramine Maleate 2 mg

Question? Comments?

Call 1-800-543-9560

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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