Other
Vicks childrens Cough Congestion
DIST. BY: PROCTER & GAMBLE, CINCINNATI, OH 45202
Made in Canada
VICKS® childrens Cough Congestion (day)
DIST. BY: PROCTER & GAMBLE, CINCINNATI, OH 45202
Made in Canada
Vicks Childrens Kit
FDA Label NDC 69423-997
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 69423-997). 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), otc - 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
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Otc - 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
- 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.
temporarily relieves common cold symptoms:
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.
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
- 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
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.
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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
- 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
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 25°C.
- 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
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
1-800-362-1683
Purpose
Cough suppressant
Expectorant
Nasal decongestant
Otc - When Using
When using this product, do not use more than directed.
Principal Display Panel - Kit Carton
DAY & NIGHT PACK
VICKS childrens Cough Congestion (Day)
Phenylephrine HCl - nasal decongestant
Dextromethorphan HBr - cough suppressant
Guaifenesin - expectorant
Non-Drowsy
FREE of:
Artificial Dyes & Flavors,
High Fructose Corn Syrup & Alcohol
- Cough
- Chest congestion
- Stuffy nose
- Cough
- Runny nose
- Stuffy nose
- Sneezing
Ages 4+
VICKS childrens Cough Congestion Night
Phenylephrine HCl - nasal decongestant
Diphenhydramine HCl - antihistamine/cough suppressant
Nighttime
FREE of:
Artificial Dyes & Flavors,
High Fructose Corn Syrup & Alcohol
Ages 6+
2 BOTTLES - 6 FL OZ (177 mL) EACH; TOTAL 12 FL OZ (354 mL)
997 (997.jpg)
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