Drug Facts
Active ingredients
(in each 5 mL teaspoonful)
Chlophedianol Hydrochloride 12.5 mg
Dexbrompheniramine Maleate 1 mg
Chlo Hist Liquid
FDA Label NDC 12830-864
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by R. A. Mcneil Company for the product Chlo Hist (NDC 12830-864). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, purpose, indications & usage, warnings, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Otc - Ask Doctor/Pharmacist
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
Otc - Pregnancy Or Breast Feeding
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
* Please review the disclaimer below.
