ED A-HIST- chlorpheniramine/phenylephrine liquid

ED A-HIST by

Drug Labeling and Warnings

ED A-HIST by is a Otc medication manufactured, distributed, or labeled by Edwards Pharmaceuticals, Inc., TG United. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ED A-HIST 
chlorpheniramine/phenylephrine liquid

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0485-0155-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/11/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/11/2011

Labeler - Edwards Pharmaceuticals, Inc. (195118880)

Establishment
Name	Address	ID/FEI	Business Operations
TG United		830980947	manufacture(0485-0155)