Label: ED-A-HIST DM- chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 66576-240-01 - Packager: Syntho Pharmaceuticals, Inc.
- 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.
Drug Label Information
Updated November 3, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies:
- runny nose.
- sneezing.
- itching of the nose or throat.
- itchy, watery eyes.
- cough due to minor throat and bronchial irritation.
- nasal congestion.
- reduces swelling of nasal passages.
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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.
Do not use this product, unless directed by a doctor, if you have
- a breathing problem such as emphysema or chronic bronchitis.
- glaucoma.
- a persistent or chronic cough that occurs with too much phlegm (mucus).
- heart disease.
- high blood pressure.
- thyroid disease.
- diabetes mellitus.
- difficulty in urination due to enlargement of the prostate gland.
Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.
When using this product
- excitability may occur, especially in children.
- may cause marked drowsiness.
- sedatives and tranquilizers may increase drowsiness effect.
- avoid alcoholic beverages.
- use caution when driving a motor vehicle or operating machinery.
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Directions
Do not exceed recommended dosage.
Adults and children 12 years of age and over: 1 tablet every 4 hours, not to exceed 6 tablets in 24 hours, or as directed by a doctor Children 6 to under 12 years of age: 1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor Children under 6 years of age: Consult a doctor. - Inactive ingredients
- Questions or Comments?
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 66576-240-01
ED A-HIST DM TABLETS
Antihistamine • Antitussive • Nasal Decongestant
Each tablet contains:
Chlorpheniramine Maleate .............. 4 mg
Dextromethorphan HBr.................. 10 mg
Phenylephrine HCl......................... 10 mgStore 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.
Berwyn, PA 19312100 tablets
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INGREDIENTS AND APPEARANCE
ED-A-HIST DM
chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66576-240 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 4 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) MAGNESIUM STEARATE (UNII: 70097M6I30) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 27 (UNII: 2LRS185U6K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color purple Score 2 pieces Shape OVAL Size 16mm Flavor Imprint Code ED;DM Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66576-240-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/02/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 11/02/2022 Labeler - Syntho Pharmaceuticals, Inc. (088797407) Registrant - Syntho Pharmaceuticals, Inc. (088797407) Establishment Name Address ID/FEI Business Operations Syntho Pharmaceuticals, Inc. 088797407 manufacture(66576-240)