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FDA LABEL GENERIC: Chlorpheniramine MFR: EDWARDS PHARMACEUTICALS, INC.

Chlorpheniramine Maleate 4 Mg / Dextromethorphan Hbr 10 Mg / Phenylephrine Hcl 10 Mg Oral Tablet

Drug Facts

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

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

Questions or Comments?

Call 1-800-543-9560   Rev. 08/14

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

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