Chlo Hist Oral Solution

Drug Facts

Composition & Product

Active Ingredients

Chlophedianol (12.5 mg) Dexbrompheniramine (1 mg)

Inactive Ingredients

Sodium Benzoate Citric Acid Monohydrate Glycerin Propylene Glycol Water Sodium Citrate Sucralose Sorbitol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2014-09-15

Medication Information

Indications and Usage

Uses A nonnaracotic cough suppressant and antihistamine for the temporary relief of:

cough due to minor throat and bronchial irritation
runny nose
sneezing
itching of the nose or throat
itchy, watery eyes

Purpose

Cough Suppressant

Antihistamine

Description

Active ingredients (in each 5 mL teaspoonful) Chlophedianol Hydrochloride 12.5 mg Dexbrompheniramine Maleate 1 mg

Section 50568-5

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Warnings

Do not exceed recommended dosage.

May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when diving a motor vehicle or operating machinery.

Directions

Do not exceed recommended dosage.

Adults and children 12 years of age and over:	2 teaspoonfuls (10 mL) every 6 hours, not to exceed 4 doses in 24 hours
Children 6 to under 12 years of age:	1 teaspoonful (5 mL) every 6 hours, not to exceed 4 doses in 24 hours
Children under 6 years of age:	Consult a Physician.

Drug Facts

Active ingredients

(in each 5 mL teaspoonful)

Chlophedianol Hydrochloride 12.5 mg

Dexbrompheniramine Maleate 1 mg

Other Information

Each 5 mL contains: Sodium 2 mg

Store at 59°-86°F (15°-30°C)

Inactive Ingredients

itric Acid, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sorbitol Solution, Sucralose.

Questions? Comments?

Serious side effects associated with use of this product may be reported to this number. Call 1-423-493-9170 (8 a.m. to 5 p.m.)

When Using This Product

excitability may occur, especially in children
may cause marked drowsiness
avoid alcoholic drinks
alcohol, sedatives, and tranquilizes may increase the drowsiness effect
be careful when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If

cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
new symptoms occur

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Product Package Label for 473 Ml

NDC 12830-864-16

Chlo HIst

Oral Solution

Cough Suppressant
Antihistamine

Grape Flavor

EACH 5 mL (1 TEASPOONFUL)

CONTAINS:

Chophedianol

Hydrochloride..................................12.5 mg

Dexbrompheniramine

Maleate................................................1 mg

Alcohol Free/Gluten Free

Sugar Free/Dye Free

ONE PINT (473 mL)

Mfg. for R.A. McNeil Company

Chattanooga, TN 37406-3738

Rev. 09/17

Tamper evident by foil seal under cap. Do not

use if foil seal is broken or missing.

Dispense in a tight, light-resistant container

with a child-resistant cap.

THIS BOTTLE IS NOT TO BE DISPENSED TO

THE CONSUMER.

Manufactured for:

R.A. McNeil Company

1150 Latta Street

Chattanooga, TN 37406-3738

US Patent # 9,050,289

Rev. 09/17

Ask A Doctor Before Use If You Have

a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
a cough that occurs with too much phlegm (mucus)
a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland

Structured Label Content

Indications and Usage (34067-9)

Uses A nonnaracotic cough suppressant and antihistamine for the temporary relief of:

cough due to minor throat and bronchial irritation
runny nose
sneezing
itching of the nose or throat
itchy, watery eyes

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Cough Suppressant

Antihistamine

Warnings

Do not exceed recommended dosage.

May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when diving a motor vehicle or operating machinery.

Directions

Do not exceed recommended dosage.

Adults and children 12 years of age and over:	2 teaspoonfuls (10 mL) every 6 hours, not to exceed 4 doses in 24 hours
Children 6 to under 12 years of age:	1 teaspoonful (5 mL) every 6 hours, not to exceed 4 doses in 24 hours
Children under 6 years of age:	Consult a Physician.

Drug Facts

Active ingredients

(in each 5 mL teaspoonful)

Chlophedianol Hydrochloride 12.5 mg

Dexbrompheniramine Maleate 1 mg

Other Information (Other information)

Each 5 mL contains: Sodium 2 mg

Store at 59°-86°F (15°-30°C)

Inactive Ingredients (Inactive ingredients)

itric Acid, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sorbitol Solution, Sucralose.

Questions? Comments?

Serious side effects associated with use of this product may be reported to this number. Call 1-423-493-9170 (8 a.m. to 5 p.m.)

When Using This Product (When using this product)

excitability may occur, especially in children
may cause marked drowsiness
avoid alcoholic drinks
alcohol, sedatives, and tranquilizes may increase the drowsiness effect
be careful when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
new symptoms occur

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Product Package Label for 473 Ml (Product Package Label for 473 mL)

NDC 12830-864-16

Chlo HIst

Oral Solution

Cough Suppressant
Antihistamine

Grape Flavor

EACH 5 mL (1 TEASPOONFUL)

CONTAINS:

Chophedianol

Hydrochloride..................................12.5 mg

Dexbrompheniramine

Maleate................................................1 mg

Alcohol Free/Gluten Free

Sugar Free/Dye Free

ONE PINT (473 mL)

Mfg. for R.A. McNeil Company

Chattanooga, TN 37406-3738

Rev. 09/17

Tamper evident by foil seal under cap. Do not

use if foil seal is broken or missing.

Dispense in a tight, light-resistant container

with a child-resistant cap.

THIS BOTTLE IS NOT TO BE DISPENSED TO

THE CONSUMER.

Manufactured for:

R.A. McNeil Company

1150 Latta Street

Chattanooga, TN 37406-3738

US Patent # 9,050,289

Rev. 09/17

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
a cough that occurs with too much phlegm (mucus)
a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Uses A nonnaracotic cough suppressant and antihistamine for the temporary relief of: cough due to minor throat and bronchial irritation runny nose sneezing itching of the nose or throat itchy, watery eyes", "50568-5": "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Cough Suppressant Antihistamine", "Warnings": "Do not exceed recommended dosage. May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when diving a motor vehicle or operating machinery.", "Directions": "Do not exceed recommended dosage. Adults and children 12 years of age and over: 2 teaspoonfuls (10 mL) every 6 hours, not to exceed 4 doses in 24 hours Children 6 to under 12 years of age: 1 teaspoonful (5 mL) every 6 hours, not to exceed 4 doses in 24 hours Children under 6 years of age: Consult a Physician.", "Drug Facts": "Active ingredients (in each 5 mL teaspoonful) Chlophedianol Hydrochloride 12.5 mg Dexbrompheniramine Maleate 1 mg", "Other information": "Each 5 mL contains: Sodium 2 mg Store at 59°-86°F (15°-30°C)", "Inactive ingredients": "itric Acid, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sorbitol Solution, Sucralose.", "Questions? Comments?": "Serious side effects associated with use of this product may be reported to this number. Call 1-423-493-9170 (8 a.m. to 5 p.m.)", "When using this product": "excitability may occur, especially in children may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizes may increase the drowsiness effect be careful when driving a motor vehicle or operating machinery", "Stop use and ask a doctor if": "cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition. new symptoms occur", "Keep out of reach of children.": "In case of overdose, get medical help or contact a Poison Control Center right away.", "Product Package Label for 473 mL": "NDC 12830-864-16 Chlo HIst Oral Solution Cough Suppressant Antihistamine Grape Flavor EACH 5 mL (1 TEASPOONFUL) CONTAINS: Chophedianol Hydrochloride..................................12.5 mg Dexbrompheniramine Maleate................................................1 mg Alcohol Free/Gluten Free Sugar Free/Dye Free ONE PINT (473 mL) Mfg. for R.A. McNeil Company Chattanooga, TN 37406-3738 Rev. 09/17 Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. Dispense in a tight, light-resistant container with a child-resistant cap. THIS BOTTLE IS NOT TO BE DISPENSED TO THE CONSUMER. Manufactured for: R.A. McNeil Company 1150 Latta Street Chattanooga, TN 37406-3738 US Patent # 9,050,289 Rev. 09/17", "Ask a doctor before use if you have": "a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema a cough that occurs with too much phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information