ED-A-HIST DM- chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride tablet

ED-A-HIST DM by

Drug Labeling and Warnings

ED-A-HIST DM by is a Otc medication manufactured, distributed, or labeled by Syntho Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients (in each tablet)	Purpose
Chlorpheniramine Maleate 4 mg	Antihistamine
Dextromethorphan HBr 10 mg	Antitussive
Phenylephrine HCl 10 mg	Nasal Decongestant

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.

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.

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur.
• cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.
• new symptoms occur.

If pregnant or breastfeeding, 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.

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

Lactose Monohydrate, Microcrystalline Cellulose, Magnesium Stearate, HPMC, Propylene Glycol, Titanium Dioxide, D&C Red #27, Blue #1.

Questions or Comments?

Call 1-800-664-1490   Rev. 9/22

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 mg

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.
Berwyn, PA 19312

100 tablets

INGREDIENTS AND APPEARANCE

ED-A-HIST DM 
chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride tablet

Product 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)