Active Ingredients In Each 5 Ml (1 Teaspoonful)
Chlophedianol HCI 12.5 mg
Dexchlorpheniramine Maleate 1 mg
Vanacof 2 Solution
FDA Label NDC 58809-190
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gm Pharmaceuticals, Inc for the product Vanacof 2 (NDC 58809-190). 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 active ingredients in each 5 ml (1 teaspoonful), purpose, uses, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Cough Suppressant
Antihistamine
Uses
■ temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
■ runny nose
■ sneezing
■ itching of the nose or throat
■ itchy, watery eyes
■ cough due to minor throat and bronchial irritation
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
■ trouble urinating due to an enlarged prostate gland
■ glaucoma
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
■ alcohol, sedatives, and tranquilizers may increase the drowsiness effect
■ avoid alcoholic drinks
■ use caution when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
■ cough 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 every 6 hours, not to exceed 8 teaspoonfuls in 24 hours. |
| children 6 to under 12 years of age: | 1 teaspoonful every 6 hours, not to exceed 4 teaspoonfuls in 24 hours |
| children under 6 years of age: | consult a doctor |
Other Information
■ this packaging is child-resistant.
■ store at room temperature of 68°-86°F (20°-30°C) with excursions of 59°-86°F (15°-30°C)
Inactive Ingredients
citric acid anhydrous, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose
Questions?
Call 1-888-535-0305 9a.m. - 5p.m. CST
Other
Distributed by: GM Pharmaceuticals, Inc. Fort Worth, TX 76118
Package Label.Principal Display Panel
NDC 58809-190-16
VanaCof® 2
EACH 5 mL (1 TEASPOONFUL) CONTAINS:
Chlophedianol HCI..........................12.5 mg
Dexchlorpheniramine Maleate............1 mg
Cough Suppressant
Antihistamine
Sugar Free, Alcohol Free, Dye Free
Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
THIS BOTTLE IS NOT TO BE DISPENSED TO CONSUMER.
Dispense in a tight, light-resistant container with a child-resistant cap.
US Patent # 9,463,191
US Patent # 9,050,289
GM Pharmaceuticals, Inc.
16 fl. oz. (473 mL)
Vanacof 2 (Vanacof 2 Daily Med)
* Please review the disclaimer below.
