Label: ED-A-HIST PSE- pseudoephedrine hydrochloride and triprolidine hydrochloride tablet, coated
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated January 13, 2022
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- 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
- heart disease
- high blood pressure
- thyroid disease
- diabetes mellitus
- difficulty in urination due to enlargement of the prostate gland
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
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
- Questions or Comments?
PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
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
INGREDIENTS AND APPEARANCE
pseudoephedrine hydrochloride and triprolidine hydrochloride tablet, coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0485-0210 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE 2.5 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) Product Characteristics Color green Score 2 pieces Shape OVAL Size 13mm Flavor Imprint Code ED;PSE Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0485-0210-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/08/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 10/08/2011 Labeler - EDWARDS PHARMACEUTICALS, INC. (195118880)