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Drug Facts
DIST. BY: PROCTER & GAMBLE, CINCINNATI, OH 45202
Made in Canada
Vicks Childrens Liquid
FDA Label NDC 37000-712
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Procter & Gamble Manufacturing Company for the product Vicks Childrens (NDC 37000-712). 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 other, active ingredients (in each 15 ml), purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients (In Each 15 Ml)
Diphenhydramine HCl 12.5 mg
Phenylephrine HCl 5 mg
Purpose
Antihistamine/Cough suppressant
Nasal decongestant
Uses
temporarily relieves common cold symptoms:
- nasal congestion
- runny nose & sneezing
- cough due to minor throat and bronchial irritation
Do Not Use
- with any other product containing diphenhydramine, even one used on skin
- to make a child sleepy
- 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
- glaucoma
- trouble urinating due to enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, or emphysema
- a sodium-restricted diet
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers
When Using This Product
- do not use more than directed.
- excitability may occur, especially in children
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
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 do not use unless directed by a doctor
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, polysorbate 20, 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 Night
Phenylephrine HCI - nasal decongestant
Diphenhydramine HCI -
antihistamine/cough suppressant
FREE of:
Artificial Dyes & Flavors,
High Fructose Corn Syrup & Alcohol
- Cough
- Runny nose
- Stuffy nose
- Sneezing
Ages 6+
6 FL OZ (177 ml)
* Please review the disclaimer below.
