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ED A-HIST by Edwards Pharmaceuticals, Inc.

Dosage form: liquid
Ingredients: Chlorpheniramine Maleate 4mg in 5mL, Phenylephrine Hydrochloride 10mg in 5mL
Labeler: Edwards Pharmaceuticals, Inc.
NDC Code: 0485-0155

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ED A-HIST LIQUID

Drug Facts Active ingredients
(in each 5 mL teaspoonful)

Chlorpheniramine Maleate 4mg
Phenylephrine Hydrochloride 10 mg
Alcohol.............................................5%

PurposeAntihistamine
Nasal Decongestant

Usestemporarily 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.

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 aretaking 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.

DirectionsDo 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.

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

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.

Questions or comments?Call 1-800-543-9560

Iss. 12/10

Product PackagingThe 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.
Ripley, MS  38663

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.

Manufactured for:  Edwards Pharmaceuticals, Inc., Ripley, MS  38663

Iss. 12/10












ED A-HIST 
chlorpheniramine/phenylephrine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0485-0155
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate4 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Glycerin 
Water 
Sodium Citrate 
Saccharin Sodium 
Sorbitol 
Propylene Glycol 
Alcohol 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0485-0155-16473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/11/2011
Labeler - Edwards Pharmaceuticals, Inc. (195118880)

Revised: 03/2011
 
Edwards Pharmaceuticals, Inc.

See also...

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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