Chlo Hist Oral Solution

Chlo Hist Oral Solution
SPL v1
SPL
SPL Set ID bca1807a-6040-4001-bce4-57c48e647ded
Route
ORAL
Published
Effective Date 2019-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlophedianol (12.5 mg) Dexbrompheniramine (1 mg)
Inactive Ingredients
Citric Acid Monohydrate Glycerin Propylene Glycol Water Sodium Citrate, Unspecified Form Saccharin Sodium Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-09-15

Description

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

Purpose

Cough Suppressant Antihistamine


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

Store at 59°-86°F (15°-30°C)

Inactive Ingredients

Citric Acid, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

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.

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
Chlophedianol Hydrochloride, Dexbrompheniramine Maleate

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)

Store at 59°-86°F (15°-30°C)

Inactive Ingredients (Inactive ingredients)

Citric Acid, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

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.

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
Chlophedianol Hydrochloride, Dexbrompheniramine Maleate

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