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  5. Label Information: Ed A-hist

FDA Label for Ed A-hist

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. PURPOSE
    3. USES
    4. DO NOT USE THIS PRODUCT
    5. DO NOT TAKE THIS PRODUCT, UNLESS DIRECTED BY A DOCTOR BEFORE USE IF YOU HAVE
    6. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    7. WHEN USING THE PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. IF PREGNANT OR BREAST-FEEDING,
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION:
    13. INACTIVE INGREDIENTS:
    14. QUESTIONS OR COMMENTS?
    15. PRODUCT PACKAGING

Ed A-hist Product Label

The following document was submitted to the FDA by the labeler of this product Edwards Pharmaceuticals, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Facts



Active ingredients(in each 5 mL teaspoonful)Chlorpheniramine Maleate 4mgPhenylephrine Hydrochloride 10 mgAlcohol.............................................5%

Purpose



AntihistamineNasal 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.

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 1-800-543-9560Iss. 12/10

Product Packaging



The packaging below represents the labeling currently used:Principal display panel and side panel for 473 mL label:NDC 0485-0155-16ED A-HIST LIQUIDANTIHISTAMINE / DECONGESTANTEach 5 mL (one teaspoonful) for oral administration contains:Chlorpheniramine Maleate..............................4 mgPhenyleprhing Hydrochloride.........................10 mgAlcohol USP.....................................................5%GLUTEN FREE / SUGAR FREEDO NOT USE IF FOIL SEAL UNDER CAP IS BROKENOR MISSINGManufactured for:EDWARDSPharmaceuticals, Inc.Ripley, MS  38663Net Contents:  1 pint (473 mL)Tamper evident by foil seal under cap.  Do not use if foil seal is brokenor 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  38663Iss. 12/10

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