Chlo Hist Oral Solution

Manufacturer
A-S Medication Solutions
Effective date
2019-01-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:58:17

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

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

Store at 59°-86°F (15°-30°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

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.)

Chlophedianol Hydrochloride, Dexbrompheniramine Maleate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1551286chlophedianol HCl 12.5 MG / dexbrompheniramine maleate 1 MG in 5 mL Oral SolutionPSN1
1551286chlophedianol hydrochloride 2.5 MG/ML / dexbrompheniramine maleate 0.2 MG/ML Oral SolutionSCD1
1551286chlophedianol hydrochloride 12.5 MG / dexbrompheniramine maleate 1 MG per 5 ML Oral SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3998-02023-01-30C16284748780-1f386c64a-3368-0266-e053-dadaa90a7c1aChlo Hist Oral Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3998-0Chlo Hist120 mL in 1 BOTTLELIQUID1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3998CHLO HIST (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE) LIQUID [A-S MEDICATION SOLUTIONS]1Legacy NDC, 1 package rows20190119_bca1807a-6040-4001-bce4-57c48e647ded.zip

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

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-399850090-3998-0
12830-864

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

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 · 2 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 (product): 12830-864
b8faec66-c1d4-445f-a343-a38f7fb49d3fbca1807a-6040-4001-bce4-57c48e647ded2019-01-16WarningsExact identifier
spl id: b8faec66-c1d4-445f-a343-a38f7fb49d3f
spl set id: bca1807a-6040-4001-bce4-57c48e647ded

Reported adverse events (FAERS/openFDA)#

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