ED A-HIST description, usages, side effects, indications, overdosage, supplying and lots more!

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ED A-HIST

Preferred Pharmaceuticals, Inc.

ED A-HIST TABLETS


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active Ingredients (in each tablet) Purpose

Chlorpheniramine Maleate 4 mg

Antihistamine

Phenylephrine HCl 10 mg

Nasal Decongestant

ED A-HIST Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • •runny nose
  • •sneezing
  • •itching of the nose or throat
  • •itchy, watery eyes
  • •nasal congestion
  • •reduces swelling of nasal passages

Warnings

  • Do not exceed recommended dosage.

Do not use this product

  • •if you are now taking a prescription monoamine 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 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

  • •a breathing problem such as emphysema or chronic bronchitis
  • •glaucoma
  • •heart disease
  • •high blood pressure
  • •thyroid disease
  • •diabetes mellitus
  • •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 this product

  • •excitability may occur, especially in children
  • •may cause drowsiness
  • •alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • •avoid alcoholic beverages
  • •use caution when 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 a fever
  • •new symptoms occur

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

Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Directions

Do not exceed recommended dosage.

Adults and children 12 years of age and over:

1 tablet every 4 hours, not to exceed 6 tablets in 24 hours, or as directed by a doctor

Children 6 to under 12 years of age:

1/2 tablet every 4 hours, not to exceed 3 tablets is 24 hours, or as directed by a doctor

Children under 6 years of age:

Consult a doctor.

Inactive ingredients

FD&C Blue #2, FD&C Yellow #5, FD&C Yellow #6, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate. Contains FD&C Yellow No. 5 (tartrazine) as a color additive

Questions or Comments?

Call 1-800-543-9560 Rev.

PRINCIPAL DISPLAY PANEL

Bottle of 30 - 68788-9481-3

ED A-HIST TABLETS

Antihistamine • Nasal Decongestant

Each tablet contains:
Chlorpheniramine Maleate 4 mg
Phenylephrine HCl 10 mg

Store at 59°-86°F (15°-30°C) [see USP Controlled Room Temperature].
Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.

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

ED A-HIST

CHLORPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68788-9481(NDC:0485-0254)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Chlorpheniramine Maleate CHLORPHENIRAMINE 4 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 10 mg

Inactive Ingredients

Ingredient Name Strength
FD&C BLUE NO. 2
FD&C YELLOW NO. 5
FD&C YELLOW NO. 6
MAGNESIUM STEARATE
cellulose, microcrystalline
sodium starch glycolate type a corn

Product Characteristics

Color Size Imprint Code Shape
BROWN (WHEAT) 13 mm E;1 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68788-9481-3 30 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2014-04-01


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Be sure to consult your doctor before taking any medication!
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