CHLO HIST- chlophedianol hydrochloride, dexbrompheniramine maleate liquid 
R. A. McNeil Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Chlo Hist Oral Solution

Drug Facts

Active ingredients

(in each 5 mL teaspoonful)

Chlophedianol Hydrochloride 12.5 mg

Dexbrompheniramine Maleate 1 mg

Purpose

Cough Suppressant

Antihistamine

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

Warnings

Do not exceed recommended dosage.

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

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



Chlo Hist Labeling 1Chlo Hist Labeling 2






CHLO HIST 
chlophedianol hydrochloride, dexbrompheniramine maleate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12830-864
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP) CHLOPHEDIANOL HYDROCHLORIDE12.5 mg  in 5 mL
DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP) DEXBROMPHENIRAMINE MALEATE1 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12830-864-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product09/15/2014
2NDC:12830-864-2020 mL in 1 BOTTLE; Type 0: Not a Combination Product09/15/2014
3NDC:12830-864-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product10/20/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/15/2014
Labeler - R. A. McNeil Company (008305220)

Revised: 11/2021
Document Id: cfd48749-c058-668c-e053-2995a90a6d64
Set id: d046f4ba-5753-4ed5-a924-0b66fd116781
Version: 7
Effective Time: 20211102
 
R. A. McNeil Company