ed-eda-histdm 0171

Drug Facts

Composition & Product

Active Ingredients

dextromethorphan (15 mg) chlorpheniramine (4 mg) phenylephrine (10 mg)

Inactive Ingredients

fd&c red no. 40 fd&c yellow no. 6 methylparaben propylparaben propylene glycol water sodium citrate sucralose citric acid monohydrate

Identifiers & Packaging

Pill Appearance

Color: yellow

Marketing Status

otc monograph drug active Since 2012-09-11

Medication Information

Warnings

Do not exceed recommended dosage.

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

Directions

Do not exceed recommended dosage

Adults and children 12 years of age and over:	1 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in 24 hours, or as directed by a doctor.
Children 6 to under 12 years of age:	1/2 teaspoonful (2.5 mL) every 4 hours, not to exceed 3 teaspoonfuls in 24 hours, or as directed by a doctor.
Children under 6 years of age:	Consult a doctor.

Other Information

Store at 59° - 86° F (15° - 30° C) [see USP for Controlled Room Temperature].

Inactive Ingredients

Artificial and Natural Banana Flavor, Citric Acid, FD&C Red #40, FD&C Yellow #6, Methyl Paraben, Propyl Paraben, Propylene Glycol, Purified Water, Sodium Citrate, Sucralose.

Description

Drug Facts

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 53414-9

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

Section 55105-1

Active Ingredients (in each 5 mL teaspoonful)	Purpose
Chlorpheniramine Maleate 4 mg	Antihistamine
Dextromethorphan HBr 15 mg	Antitussive
Phenylephrine HCl 10 mg	Nasal Decongestant

Question? Comments?

Call 1-800-543-9560

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 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 473 Ml Bottle Label

E

NDC 0485-0171-16

ED A-HIST DM

Antihistamine • Antitussive

• Nasal Decongestant

Sugar Free • Gluten Free

Each teaspoonful (5 mL)

for oral administration contains:

Chlorpheniramine Maleate 4 mg

Dextromethorphan HBr 15 mg

Phenylephrine HCl 10 mg

Banana Flavor

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

16oz. (473 mL)

Structured Label Content

Warnings

Do not exceed recommended dosage.

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

Directions

Do not exceed recommended dosage

Adults and children 12 years of age and over:	1 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in 24 hours, or as directed by a doctor.
Children 6 to under 12 years of age:	1/2 teaspoonful (2.5 mL) every 4 hours, not to exceed 3 teaspoonfuls in 24 hours, or as directed by a doctor.
Children under 6 years of age:	Consult a doctor.

Other Information (Other information)

Store at 59° - 86° F (15° - 30° C) [see USP for Controlled Room Temperature].

Inactive Ingredients (Inactive ingredients)

Artificial and Natural Banana Flavor, Citric Acid, FD&C Red #40, FD&C Yellow #6, Methyl Paraben, Propyl Paraben, Propylene Glycol, Purified Water, Sodium Citrate, Sucralose.

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 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Active Ingredients (in each 5 mL teaspoonful)	Purpose
Chlorpheniramine Maleate 4 mg	Antihistamine
Dextromethorphan HBr 15 mg	Antitussive
Phenylephrine HCl 10 mg	Nasal Decongestant

Question? Comments?

Call 1-800-543-9560

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.

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 (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 Doctor If (Stop use and ask 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 473 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label)

E

NDC 0485-0171-16

ED A-HIST DM

Antihistamine • Antitussive

• Nasal Decongestant

Sugar Free • Gluten Free

Each teaspoonful (5 mL)

for oral administration contains:

Chlorpheniramine Maleate 4 mg

Dextromethorphan HBr 15 mg

Phenylephrine HCl 10 mg

Banana Flavor

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

16oz. (473 mL)

Advanced Ingredient Data

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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.", "53414-9": "If pregnant or breastfeeding, ask a health professional before use.", "55105-1": "Active Ingredients (in each 5 mL teaspoonful) Purpose Chlorpheniramine Maleate 4 mg Antihistamine Dextromethorphan HBr 15 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 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: 1/2 teaspoonful (2.5 mL) every 4 hours, not to exceed 3 teaspoonfuls in 24 hours, or as directed by a doctor. Children under 6 years of age: Consult a doctor.", "Other information": "Store at 59° - 86° F (15° - 30° C) [see USP for Controlled Room Temperature].", "Question? Comments?": "Call 1-800-543-9560", "Inactive ingredients": "Artificial and Natural Banana Flavor, Citric Acid, FD&C Red #40, FD&C Yellow #6, Methyl Paraben, Propyl Paraben, Propylene Glycol, Purified Water, Sodium Citrate, Sucralose.", "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 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 - 473 mL Bottle Label": "E NDC 0485-0171-16 ED A-HIST DM Antihistamine • Antitussive • Nasal Decongestant Sugar Free • Gluten Free Each teaspoonful (5 mL) for oral administration contains: Chlorpheniramine Maleate 4 mg Dextromethorphan HBr 15 mg Phenylephrine HCl 10 mg Banana Flavor 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 16oz. (473 mL)"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information