FDA Label for Vicks Childrens Cough Congestion
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENTS (IN EACH 15 ML)
- PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- OTC - WHEN USING
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - 177 ML BOTTLE LABEL
Vicks Childrens Cough Congestion Product Label
The following document was submitted to the FDA by the labeler of this product The Procter & Gamble Manufacturing Company. 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.
Other
Drug Facts
DIST. BY: PROCTER & GAMBLE, CINCINNATI, OH 45202
Made in Canada
Active Ingredients (In Each 15 Ml)
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Purpose
Cough suppressant
Expectorant
Nasal decongestant
Uses
temporarily relieves common cold symptoms:
- nasal congestion
- cough due to minor throat and bronchial irritation
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
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 for 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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
- a sodium-restricted diet
Otc - When Using
When using this product, do not use more than directed.
Stop Use And Ask A Doctor If
- you get nervous, dizzy or sleepless
- symptoms do not improve within 7 days or occur with a fever
- cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache
These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose Warning
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- take only as directed
- use dose cup provided
- do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over 30 mL every 4 hrs
children 6 to under 12 yrs 15 mL every 4 hrs
children 4 to under 6 yrs 7.5 mL every 4 hrs
children under 4 yrs do not use
Other Information
- each 15 mL contains: sodium 44 mg
- store at no greater than 25°C.
Inactive Ingredients
anhydrous citric acid, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose
Questions?
1-800-362-1683
Principal Display Panel - 177 Ml Bottle Label
VICKS ®
children's
Cough
Congestion
Non-Drowsy
Phenylephrine HCI - nasal decongestant
Dextromethorphan HBr - cough suppressant
Guaifenesin - expectorant
FREE of:
Artificial Dyes & Flavors,
High Fructose Corn Syrup & Alcohol
Cough
Chest congestion
Stuffy nose
Ages 4+
6 FL OZ (177 ml)
* Please review the disclaimer below.