ED A-HIST by Edwards Pharmaceuticals, Inc.
Dosage form: liquid
Ingredients: Chlorpheniramine Maleate 4mg in 5mL, Phenylephrine Hydrochloride 10mg in 5mL
Labeler: Edwards Pharmaceuticals, Inc.
NDC Code: 0485-0155
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Facts
Active ingredients
(in each 5 mL teaspoonful)
Chlorpheniramine Maleate 4mg
Phenylephrine Hydrochloride 10 mg
Alcohol.............................................5%
(in each 5 mL teaspoonful)
Chlorpheniramine Maleate 4mg
Phenylephrine Hydrochloride 10 mg
Alcohol.............................................5%
PurposeAntihistamine
Nasal Decongestant
Nasal Decongestant
Usestemporarily 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 aretaking 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.
DirectionsDo not exceed recommended dosage.
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.
| 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 |
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
Iss. 12/10
Product PackagingThe 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
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
chlorpheniramine/phenylephrine liquid |
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
| Labeler - Edwards Pharmaceuticals, Inc. (195118880) |
Revised: 03/2011
Document Id: 302e2918-16aa-45a1-b87b-2feda0e0297d
Set id: bf5c4a23-9581-4b84-a75b-e17e1d768970
Version: 2
Effective Time: 20110323
Edwards Pharmaceuticals, Inc.
See also...
- ED A-HIST (2 labels)
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
