ED A-HIST CHLORPHENIRAMINE PHENYLEPHRINE EDWARDS PHARMACEUTICALS, INC. FDA Approved Uses temporarily relieves runny nose and nasal congestion due to the common cold, hay fever or other upper respiratory allergies allergic rhinitis), relieves sneezing, itching of the nose or throat, itchy watery eyes, and reduces swelling of the nasal passages.
FunFoxMeds bottle
Route
ORAL
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Drug Facts Active ingredients (in each 5 mL teaspoonful) Chlorpheniramine Maleate 4mg Phenylephrine Hydrochloride 10 mg Alcohol.............................................5%
Inactive Ingredients
Inactive ingredients: FD and C Blue #1 Grape Flavor Glycerin Propylene Glycol Purified Water Sodium Citrate Sodium Saccharin Sorbitol and FD and C Red #40.
Strengths
5 ml 4 mg 10 mg 5 %
Quantities
473 ml 5 ml
Treats Conditions
Uses Temporarily Relieves Runny Nose And Nasal Congestion Due To The Common Cold Hay Fever Or Other Upper Respiratory Allergies Allergic Rhinitis Relieves Sneezing Itching Of The Nose Or Throat Itchy Watery Eyes And Reduces Swelling Of The Nasal Passages

Identifiers & Packaging

Container Type BOTTLE
All Product Codes
UPC
0304850155164
UNII
V1Q0O9OJ9Z 04JA59TNSJ
Packaging

Product Packaging The packaging below represents the labeling currently used: Principal display panel and side panel for 473 mL label: NDC 0485-0155-16 ED A-HIST LIQUID ANTIHISTAMINE / DECONGESTANT Each 5 mL (one teaspoonful) for oral administration contains: Chlorpheniramine Maleate..............................4 mg Phenyleprhing Hydrochloride.........................10 mg Alcohol USP.....................................................5% GLUTEN FREE / SUGAR FREE DO NOT USE IF FOIL SEAL UNDER CAP IS BROKEN OR MISSING Manufactured for: EDWARDS Pharmaceuticals, Inc. Paoli, PA 19301 Net Contents: 1 pint (473 mL) Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. dispense in a tight, light-resistant container with a child-resistant closure. This bottle is not to be dispensed to consumer. label

Package Descriptions
  • Product Packaging The packaging below represents the labeling currently used: Principal display panel and side panel for 473 mL label: NDC 0485-0155-16 ED A-HIST LIQUID ANTIHISTAMINE / DECONGESTANT Each 5 mL (one teaspoonful) for oral administration contains: Chlorpheniramine Maleate..............................4 mg Phenyleprhing Hydrochloride.........................10 mg Alcohol USP.....................................................5% GLUTEN FREE / SUGAR FREE DO NOT USE IF FOIL SEAL UNDER CAP IS BROKEN OR MISSING Manufactured for: EDWARDS Pharmaceuticals, Inc. Paoli, PA 19301 Net Contents: 1 pint (473 mL) Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. dispense in a tight, light-resistant container with a child-resistant closure. This bottle is not to be dispensed to consumer. label

Overview

Uses temporarily relieves runny nose and nasal congestion due to the common cold, hay fever or other upper respiratory allergies allergic rhinitis), relieves sneezing, itching of the nose or throat, itchy watery eyes, and reduces swelling of the nasal passages.

Indications & Usage

Uses temporarily relieves runny nose and nasal congestion due to the common cold, hay fever or other upper respiratory allergies allergic rhinitis), relieves sneezing, itching of the nose or throat, itchy watery eyes, and reduces swelling of the nasal passages.

Dosage & Administration

Directions Do not exceed recommended dosage. Adults and children 12 years of age and over: 1 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in a 24 hour period Children 6 to under 12 years of age: 1/2 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in a 24 hour period Children under 6 years of age: Consult a Doctor A special measuring device should be used to give an accurate dose of this product to children under 12 years of age. Giving a higher dose than recommended by a doctor could result in serious side effects for your child.

Warnings & Precautions
Warnings: Do not exceed recommended dosage. Do not use this product if you are now taking prescription monaimine 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 know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Do not take this product, unless directed by a doctor before use if you have A breathing problem such as emphysema or chronic bronchitis Glaucoma, heart disease, diabetes, high blood pressure or thyroid disease Difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using the product May cause drowsiness Avoid alcoholic beverages Alcohol, sedatives, and tranquilizers may increase drowsiness Be careful when driving a motor vehicle or operating machinery Excitability may occur, especially in children. Stop use and ask a doctor if Nervousness, dizziness, or sleeplessness occurs Symptoms do not improve within 7 days or are accompanied by 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 right away.
Purpose

Purpose Antihistamine.........................Nasal Decongestant

Do Not Use

Do not use this product if you are now taking prescription monaimine 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 know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Do not take this product, unless directed by a doctor before use if you have A breathing problem such as emphysema or chronic bronchitis Glaucoma, heart disease, diabetes, high blood pressure or thyroid disease Difficulty in urination due to enlargement of the prostate gland

When Using

When using the product May cause drowsiness Avoid alcoholic beverages Alcohol, sedatives, and tranquilizers may increase drowsiness Be careful when driving a motor vehicle or operating machinery Excitability may occur, especially in children.

Stop Use & Ask a Doctor

Stop use and ask a doctor if Nervousness, dizziness, or sleeplessness occurs Symptoms do not improve within 7 days or are accompanied by a fever.

Keep Out of Reach of Children

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

Storage & Handling

Other information: Store at 59° - 86°F (15° - 30°C)

Questions

Questions or comments? Call 1-800-543-9560 Iss. 12/10


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