FDA Label for Vanacof 2
View Indications, Usage & Precautions
- 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,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- OTHER
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Vanacof 2 Product Label
The following document was submitted to the FDA by the labeler of this product Gm Pharmaceuticals, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients In Each 5 Ml (1 Teaspoonful)
Chlophedianol HCI 12.5 mg
Dexchlorpheniramine Maleate 1 mg
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)
* Please review the disclaimer below.
