ED A-HIST- chlorpheniramine/phenylephrine liquid 
Edwards Pharmaceuticals, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ED A-HIST LIQUID

Drug Facts

Active ingredients (in each 5 mL teaspoonful)

Chlorpheniramine Maleate 4mg

Phenylephrine Hydrochloride 10 mg

Alcohol.............................................5%

Purpose

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

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.

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.

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.

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 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.
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 Liquid Packaging



ED A-HIST Liquid Packaging








ED A-HIST 
chlorpheniramine/phenylephrine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0485-0155
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALCOHOL (UNII: 3K9958V90M)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0485-0155-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/11/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/11/2011
Labeler - Edwards Pharmaceuticals, Inc. (195118880)
Establishment
NameAddressID/FEIBusiness Operations
Syntho Pharmaceuticals088797407manufacture(0485-0155)

Revised: 1/2024
Document Id: 0ed918a2-2e61-7e98-e063-6394a90a2886
Set id: bf5c4a23-9581-4b84-a75b-e17e1d768970
Version: 5
Effective Time: 20240113
 
Edwards Pharmaceuticals, Inc.