Active Ingredients (In Each 15 Ml (1Tbsp))
Chlophedianol HCl 12.5 mg
Pyrilamine Maleate 25 mg
Vanacof Cp Allergy / Cough Solution
FDA Label NDC 58809-189
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 Cp Allergy / Cough (NDC 58809-189). 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 15 ml (1tbsp)), purpose, uses, ask a doctor before use if you have, ask a doctor 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 or other upper respiratory allergies:
■ runny nose ■ itching of the nose or throat
■ sneezing ■ 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
■ glaucoma
■ difficulty in urination due to enlargement of the prostate gland
■ a cough that occurs with too much phlegm (mucus)
■ a breathing problem such as emphysema or chronic bronchitis
Ask A Doctor Before Use If You Are
taking sedatives or tranquilizers
When Using This Product
■ do not use more than directed ■ avoid alcoholic drinks
■ marked drowsiness may occur
■ alcohol, sedatives, and tranquilizers may increase drowsiness
■ be careful when driving a motor vehicle or operating machinery
■ excitability may occur, especially in children
Stop Use And Ask A Doctor If
- ■ nervousness, dizziness, or sleeplessness occurs
- ■ symptoms do not improve within 7 days, tend to recur, or are 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 take more than 4 doses in any 24-hour period
■ dose as follows or as directed by a doctor ■ mL= milliliter
| adults and children 12 years of age and over: | 30 mL (2 TBSP) every 6 to 8 hours, not to exceed 120 mL (8 TBSP) per 24 hours |
| children 6 to under 12 years of age: | 15 mL (1 TBSP) every 6 to 8 hours, not to exceed 60 mL (4 TBSP) per 24 hours |
| children under 6 years: | consult a doctor. |
Other Information
■ store at 20° to 30°C (68° to 86°F)
■ each 15 mL (1 TBSP) contains: Sodium 8.5 mg
Inactive Ingredients
citric acid anhydrous, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol
Questions?
1-888-535-0305 9 a.m. - 5 p.m. CST
Other Safety Information
Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
Other
U.S. Pat: 9,463,191
Distributed by: GM Pharmaceuticals, Inc. Fort Worth, TX 76118
Package Label.Principal Display Panel
NDC 58809-189-08
VANACOF® CP
Allergy / Cough
Each 15 mL (1 TBSP) contains:
Chlophedianol HCl .................... 12.5 mg
Pyrilamine Maleate ....................... 25 mg
Cough Suppressant • Antihistamine
Alcohol Free / Sugar Free / Gluten Free / Dye Free
GM Pharmaceuticals, Inc.
8 fl oz (237 mL)
Vanacof Cp (Vanacof Cp)
* Please review the disclaimer below.
