Active Ingredients (In Each 15 Ml (1Tbsp))
Dextromethorphan HBr 18 mg
Guaifenesin 396 mg
Vanacof Xp Cough / Chest Congestion Solution
FDA Label NDC 58809-187
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 Xp Cough / Chest Congestion (NDC 58809-187). 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, do not use, ask a doctor before use if you have, 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
Expectorant
Uses
- ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- ■ temporarily relieves:
■ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
■ the intensity of coughing
■ the impulse to cough to help you get to sleep
Do Not Use
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask A Doctor Before Use If You Have
- ■ a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- ■ a cough that occurs with too much phlegm (mucus)
When Using This Product
do not use more than directed
Stop Use And Ask A Doctor If
■ cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
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 6 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: | 15 mL (1 TBSP) every 4 hours, not to exceed 90 mL (6 TBSP) per 24 hours |
| children 6 to under 12 years of age: | 7.5 mL (1/2 TBSP) every 4 hours, not to exceed 45 mL (3 TBSP) per 24 hours |
| children under 6 years: | consult a doctor. |
Other Information
■ each 15 mL (1 TBSP) contains: Sodium 6 mg
Storage And Handling
■ store at 20° to 30°C (68° to 86°F)
Inactive Ingredients
citric acid, flavors, glycerin, l-menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum
Questions Or Comments?
1-888-535-0305 9 a.m. - 5 p.m. CST
Other
Tamper evident by foil seal under cap. Do no usei f foil seal is broken or missing.
Package Label.Principal Display Panel
NDC 58809-187-08
VANACOF® XP
COUGH / CHEST CONGESTION
Each 15 mL (1 TBSP) contains:
Dextromethorphan HBr.....18 mg
Guaifenesin ....................396 mg
Cough Suppressant ■ Expectorant
Raspberry-Mint Flavor
Alcohol Free / Sugar Gree / Gluten Free / Dye Free
Labeling (Vanacof Xp)
* Please review the disclaimer below.
