Ed-a-hist Dm Tablets

Drug Facts

Composition & Product

Active Ingredients

Chlorpheniramine (4 mg) Dextromethorphan (10 mg) Phenylephrine

Inactive Ingredients

Magnesium Stearate Cellulose, Microcrystalline Sodium Starch Glycolate Type A Corn Fd&c Red No. 40 Fd&c Blue No. 2

Identifiers & Packaging

Pill Appearance

Imprint: ED;DM Shape: oval Color: purple Size: 16 mm Score: 2

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2014-10-27

Medication Information

Description

Drug Facts

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

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50568-5

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

Section 50569-3

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

Section 53414-9

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

Section 55105-1

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

Warnings

Do not exceed recommended dosage.

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

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

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

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

Structured Label Content

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

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

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

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

Warnings

Do not exceed recommended dosage.

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 (Inactive ingredients)

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

Questions Or Comments? (Questions or Comments?)

Call 1-800-543-9560 Rev. 08/14

Do Not Use This Product (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

When Using This Product (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 (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

Principal Display Panel 100 Tablet Bottle Label (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

Advanced Ingredient Data

[{"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A CORN", "unii": "AG9B65PV6B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 2", "unii": "L06K8R7DQK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CHLORPHENIRAMINE", "unii": "3U6IO1965U", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"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", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.", "50568-5": "Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.", "50569-3": "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", "53414-9": "If pregnant or breastfeeding, ask a health professional before use.", "55105-1": "Active Ingredients (in each tablet) Purpose Chlorpheniramine Maleate 4 mg Antihistamine Dextromethorphan HBr 10 mg Antitussive Phenylephrine HCl 10 mg Nasal Decongestant", "Warnings": "Do not exceed recommended dosage.", "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", "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", "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", "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"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information