Dosage form: tablet, coated
Ingredients: PSEUDOEPHEDRINE HYDROCHLORIDE 60mg, TRIPROLIDINE HYDROCHLORIDE 2.5mg
Labeler: EDWARDS PHARMACEUTICALS, INC.
NDC Code: 0485-0210
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.
|Active Ingredients (in each tablet)||Purpose|
|Pseudoephedrine HCI 60 mg||Nasal Decongestant|
|Triprolidine HCI 2.5 mg.||Antihistamine|
temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
- runny nose
- itching of the nose or throat
- itchy, watery eyes
- nasal congestion
- reduces swelling of nasal passages
- Do not exceed recommended dosage.
- 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.
- a breathing problem such as emphysema or chronic bronchitis
- 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
- excitability may occur, especially in children
- may cause drowsiness
- alcohol, sedatives and tranquilizers may increase drowsiness effect
- avoid alcoholic beverages
- use caution when driving a motor vehicle or operating machinery
- nervousness, dizziness, or sleeplessness occur
- symptoms do not improve within 7 days or are accompanied by 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.
Do not exceed recommended dosage.
|Adults and children 12 years of age and over:||1 tablet every 4-6 hours, not to exceed 4 tablets in 24 hours, or as directed by a doctor|
|Children 6 to under 12 years of age:||1/2 tablet every 4-6 hours, not to exceed 2 tablets in 24 hours, or as directed by a doctor|
|Children under 6 years of age:||Consult a doctor.|
FD&C Blue #2, FD&C Yellow #5, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate.
Contains FD&C Yellow No. 5 (tartrazine) as a color additive.
ED A-HIST PSE TABLETS
Nasal Decongestant • Antihistamine
Each tablet contains:
Pseudoephedrine HCI 60 mg
Triprolidine HCI 2.5 mg
This bottle is not to be dispensed to consumer.
Dispense in a tight, light-resistant container
with a child-resistant cap.
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.
Pharmaceuticals, Inc .
Ripley, MS 38663
pseudoephedrine hydrochloride and triprolidine hydrochloride tablet, coated
|Labeler - EDWARDS PHARMACEUTICALS, INC. (195118880)|
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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.