ED A-HIST  - chlorpheniramine maleate and phenylephrine hydrochloride liquid 
Edwards Pharmaceuticals

----------

Drug Facts

Active ingredients

(in each teaspoonful (5mL))

Chlorpheniramine Maleate 4mg

Phenylephrine Hydrochloride 10mg

Active ingredient                                     Purpose

Chlorpheniramine Maleate 4mg            Antihistamine

Phenylephrine HCl    10mg                    Nasal Decongestant

Uses  temporarily relieves these symptoms due to cold, hay fever or upper respiratory allergies (allergic rhinitis)

• runny nose, sneezing, itchy watery eyes
• nasal stuffiness
• nasal congestion and pressure
  

Warnings

Do not exceed recommended dosage

Do not use if you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, Parkinson's disease), or for 2 weeks after stopping the MAOI drug.  If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• heart disease
• diabetes
• glaucoma
• high blood pressure
• thyroid disease
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis
  

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product

• may cause excitability especially in children
• may cause drowsiness: alcohol, sedatives, and tranquilizers may increase drowsiness
• avoid alcoholic beverages while taking this product
• use caution while driving a motor vehicle or operating machinery
  

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• symptoms do not improve within 7 days or are accompanied by fever
  

If pregnant or breast-feeding, ask a health professional before use

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

Directions  do not take more than 6 doses in 24 hours

adults and children 12 years and over	1 tsp (5mL) every 4-6 hours
children 6 years to under 12	1/2 tsp (2.5 mL every 4-6 hours
children under 6 years of age	Consult a doctor

Store at controlled room temperature 15-30C (59-86F)

To report serious side effects associated with the use of this product call 1-800-543-9560

Inactive ingredients Alcohol,  FD and C Blue #1, FD and C Red #40, Glycerin, grape flavor, Propylene Glycol, Purified Water, Sodium Saccharin, and Sorbitol

Enter section text here

ED A-HIST  chlorpheniramine/phenylephrine   liquid

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0485-0155 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 4 mg  in 5 mL PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 10 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength ALCOHOL   FD&C BLUE NO. 1   FD&C RED NO. 40   GLYCERIN   PROPYLENE GLYCOL   WATER   SACCHARIN SODIUM   SORBITOL

Product Characteristics Color      Score      Shape Size Flavor GRAPE (GRAPE) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0485-0155-16 473 mL In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/30/2011

Labeler - Edwards Pharmaceuticals (195118880)

Registrant - Elge, Inc. (610655136)

Establishment
Name	Address	ID/FEI	Operations
Elge, Inc.		610655136	manufacture

Revised: 01/2011Edwards Pharmaceuticals