FDA.reportPublic FDA data

Chlo Hist Oral Solution

Manufacturer
R. A. McNeil Company
Effective date
2025-10-15
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-06-01 01:39:13

Label at a glance#

ProductChlo Hist
Active ingredientCHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE
Label structure8 sections

Dosage and administration

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.

Storage and handling

Each 5 mL contains: Sodium 2 mg Store at 59°-86°F (15°-30°C)

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

(in each 5 mL teaspoonful)

Chlophedianol Hydrochloride 12.5 mg

Dexbrompheniramine Maleate 1 mg

Purpose

OTC - PURPOSE SECTION

Cough Suppressant

Antihistamine

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

Each 5 mL contains: Sodium 2 mg

Store at 59°-86°F (15°-30°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions? Comments?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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





labellabel



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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1551286chlophedianol HCl 12.5 MG / dexbrompheniramine maleate 1 MG in 5 mL Oral SolutionPSN13
1551286chlophedianol hydrochloride 2.5 MG/ML / dexbrompheniramine maleate 0.2 MG/ML Oral SolutionSCD13
1551286chlophedianol hydrochloride 12.5 MG / dexbrompheniramine maleate 1 MG per 5 ML Oral SolutionSY13

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
12830-864-042022-12-22C16284748780-1e4f33bdf-9db2-d8a0-e053-dadaa90a6e4eChlo Hist Oral Solution
12830-864-042022-12-22C16284748780-1e4f33bdf-9db2-d8a0-e053-dadaa90a6e4eChlo Hist Oral Solution
12830-864-162022-12-22C16284748780-1e4f33bdf-9db2-d8a0-e053-dadaa90a6e4eChlo Hist Oral Solution
12830-864-162022-12-22C16284748780-1e4f33bdf-9db2-d8a0-e053-dadaa90a6e4eChlo Hist Oral Solution
12830-864-202022-12-22C16284748780-1e4f33bdf-9db2-d8a0-e053-dadaa90a6e4eChlo Hist Oral Solution
12830-864-202022-12-22C16284748780-1e4f33bdf-9db2-d8a0-e053-dadaa90a6e4eChlo Hist Oral Solution
12830-864-042022-07-29C16284748780-1e4f33bdf-9db2-d8a0-e053-dadaa90a6e4eChlo Hist Oral Solution
12830-864-042022-07-29C16284748780-1e4f33bdf-9db2-d8a0-e053-dadaa90a6e4eChlo Hist Oral Solution
12830-864-162022-07-29C16284748780-1e4f33bdf-9db2-d8a0-e053-dadaa90a6e4eChlo Hist Oral Solution
12830-864-162022-07-29C16284748780-1e4f33bdf-9db2-d8a0-e053-dadaa90a6e4eChlo Hist Oral Solution
12830-864-202022-07-29C16284748780-1e4f33bdf-9db2-d8a0-e053-dadaa90a6e4eChlo Hist Oral Solution
12830-864-202022-07-29C16284748780-1e4f33bdf-9db2-d8a0-e053-dadaa90a6e4eChlo Hist Oral Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12830-864-04Chlo Hist120 mL in 1 BOTTLELIQUID12013
12830-864-16Chlo Hist473 mL in 1 BOTTLELIQUID47313
12830-864-20Chlo Hist20 mL in 1 BOTTLELIQUID2013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
12830-864-04ML - Milliliter12830-86463e03d4b-e950-44f7-a936-0e40e6136f0012018-01-12
12830-864-16ML - Milliliter12830-86412c5c59a-9f05-47bc-925f-d6c925c8739012014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CHLOPHEDIANOL HYDROCHLORIDEACTIVE INGREDIENT69QQ58998Y2
DEXBROMPHENIRAMINE MALEATEACTIVE INGREDIENTBPA9UT29BS2
CHLOPHEDIANOLACTIVE MOIETY42C50P12AP2
DEXBROMPHENIRAMINEACTIVE MOIETY75T64B71RP2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V32
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR2
SORBITOLINACTIVE INGREDIENT506T60A25R2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
12830-86412830-864-16, 12830-864-20, 12830-864-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM BENZOATEOJ245FE5EUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM CITRATE1Q73Q2JULRIACT
SUCRALOSE96K6UQ3ZD4IACT
SORBITOL506T60A25RIACT
CHLOPHEDIANOL HYDROCHLORIDE69QQ58998YACTIB
DEXBROMPHENIRAMINE MALEATEBPA9UT29BSACTIB

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
122024-03-15full-release2026-06-01 00:10:04

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 20 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / ORAL114 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / ORAL114 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYLIQUID / ORAL3 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYLIQUID / ORAL3 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / ORAL114 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYLIQUID / ORAL3 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / ORAL114 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYLIQUID / ORAL3 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chlo HistCHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATER. A. McNeil Companyd046f4ba-5753-4ed5-a924-0b66fd1167812025-10-15WarningsExact identifier
ndc (package): 12830-864-16
ndc (package): 12830-864-04
ndc (package): 12830-864-20
ndc (product): 12830-864
ndc11 (package): 12830086420
ndc11 (package): 12830086416
ndc11 (package): 12830086404
spl id: 413d8eeb-e320-427b-e063-6394a90a9fe4
spl set id: d046f4ba-5753-4ed5-a924-0b66fd116781

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.