FDA Label for Ed-a-hist Pse
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USES
- WARNINGS
- DO NOT USE THIS PRODUCT
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- OTC - ASK DOCTOR/PHARMACIST
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL - 100 TABLET BOTTLE LABEL
Ed-a-hist Pse 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.
Other
Drug Facts
Otc - Purpose
| Active Ingredients (in each tablet) | Purpose |
|---|---|
| Pseudoephedrine HCI 60 mg | Nasal Decongestant |
| Triprolidine HCI 2.5 mg. | Antihistamine |
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
Otc - Ask Doctor/Pharmacist
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 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 fever
- new symptoms occur
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use,
Otc - Keep Out Of Reach Of Children
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 4-6 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. |
Inactive Ingredients
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.
Questions Or Comments?
Call 1-800-543-9560
Rev. 11/11
Principal Display Panel - 100 Tablet Bottle Label
NDC 00485-0210-01
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.
Manufactured for:
EDWARDS
Pharmaceuticals, Inc .
Ripley, MS 38663
100 tablets
* Please review the disclaimer below.