ED-A-HIST DM TABLETS

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SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

• Do not exceed recommended dosage.

Do not use this product

OTC - DO NOT USE SECTION

• 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

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.

When using this product

OTC - WHEN USING SECTION

• 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

OTC - STOP USE SECTION

• 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

Lake blend purple, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-800-543-9560   Rev. 08/14

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0485-0240-01

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.
Ripley, MS 38663

100 tablets

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

• ED-A-HIST DM
• CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
• MAGNESIUM STEARATE
• CELLULOSE, MICROCRYSTALLINE
• SODIUM STARCH GLYCOLATE TYPE A CORN
• FD&C RED NO. 40
• FD&C BLUE NO. 2
• CHLORPHENIRAMINE MALEATE
• CHLORPHENIRAMINE
• DEXTROMETHORPHAN HYDROBROMIDE
• DEXTROMETHORPHAN
• PHENYLEPHRINE HYDROCHLORIDE
• PHENYLEPHRINE

NDC Codes#

Ingredients#

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DailyMed ingredient rows page 1 of 1 · 8 matching rows.

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Inactive ingredient matches#

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Inactive ingredient links page 1 of 1 · 8 matching rows.

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Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.