CHLO HIST- chlophedianol hydrochloride, dexbrompheniramine maleate liquid

Chlo Hist by

Drug Labeling and Warnings

Chlo Hist by is a Otc medication manufactured, distributed, or labeled by R. A. McNeil Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

(in each 5 mL teaspoonful)

Chlophedianol Hydrochloride 12.5 mg

Dexbrompheniramine Maleate 1 mg

Purpose

Cough Suppressant

Antihistamine

INDICATIONS & 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

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.

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

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

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

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

Keep out of reach of children.

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

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.

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.)

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

INGREDIENTS AND APPEARANCE

CHLO HIST 
chlophedianol hydrochloride, dexbrompheniramine maleate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12830-864
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP)	CHLOPHEDIANOL HYDROCHLORIDE	12.5 mg  in 5 mL
DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP)	DEXBROMPHENIRAMINE MALEATE	1 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12830-864-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/15/2014
2	NDC: 12830-864-20	20 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/15/2014
3	NDC: 12830-864-04	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/20/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/15/2014

Labeler - R. A. McNeil Company (008305220)

Establishment
Name	Address	ID/FEI	Business Operations
Woodfield Pharmaceutical, LLC		079398730	manufacture(12830-864)