FDA Label for Vicks Childrens Cold Multi Symptom
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENTS (IN EACH 15 ML)
- PURPOSE
- USES
- LIVER WARNING
- ALLERGY ALERT:
- SORE THROAT WARNING
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- OTC - WHEN USING
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - 177 ML BOTTLE LABEL
Vicks Childrens Cold Multi Symptom Product Label
The following document was submitted to the FDA by the labeler of this product 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
In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.
DIST. BY: PROCTER & GAMBLE, CINCINNATI, OH 45202
Made in Canada
Active Ingredients (In Each 15 Ml)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Purpose
Pain reliever/Fever reducer
Cough suppressant
Nasal decongestant
Uses
temporarily relieves common cold/flu symptoms:
- nasal congestion
- cough due to minor throat & bronchial irritation
- sore throat
- headache
- minor aches & pains
- fever
Liver Warning
This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product
- child takes more than 4 doses (15 mL each) in 24 hours, which is the maximum daily amount for this product
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks daily while using this product
Allergy Alert:
Acetaminophen may cause severe skin reactions. Symptoms may include:
- Skin reddening
- Blisters
- Rash
If a skin reaction occurs, stop use and seek medical help right away
Sore Throat Warning
If sore throat is severe, persists for more than 2 days, is accompanied or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do Not Use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- 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
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- peristent or chronic cough such as occurs with smoking, asthma, or emphysema
- a sodium-restricted diet
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin
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
- pain, nasal congestion or cough gets worse or lasts more than 5 days (children) 7 days (adults)
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back, or occurs with rash or headache that lasts.
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.
Directions
- take only as directed
- only use the 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 ask a doctor
children under 4 yrs do not use
Other Information
- each 15 mL contains: sodium 44 mg
- Store at no greater than 25C. Do not refrigerate.
Inactive Ingredients
anhydrous citric acid, beta carotene, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum
Questions?
1-800-362-1683
Principal Display Panel - 177 Ml Bottle Label
VICKS®
children's
Cold
MULTI-SYMPTOM
Acetaminophen - pain reliever/fever reducer
Dextromethorphan HBr - cough suppressant
Phenylephrine HCl - nasal decongestant
FREE of:
Artificial Dyes & Flavors,
High Fructose Corn Syrup & Alcohol
- Aches, Fever
- Sore Throat
- Cough
- Stuffy nose
Ages 6+
6 FL OZ (177 ml)
* Please review the disclaimer below.