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Name:Vicks Vaposyrup
Manufacturer:The Procter & Gamble Manufacturing Company
Category:Over-the-counter (OTC) Marketed Drugs


VICKS® VapoSyrup™SEVERE CONGESTION

VICKS VAPOSYRUP - guaifenesin and phenylephrine hydrochloride liquid 
The Procter & Gamble Manufacturing Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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VICKS®
VapoSyrup™
SEVERE CONGESTION

Drug Facts

Active ingredients (in each 15 ml tablespoon)

Guaifenesin 100 mg

Phenylephrine HCl 5 mg

Purpose

Expectorant

Nasal decongestant

Uses

  • helps loosen phlegm and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
  • temporarily relieves nasal congestion due to a cold or hay fever or other upper respiratory allergies

Warnings

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
  • thyroid disease
  • diabetes
  • high blood pressure
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • a sodium-restricted diet

When using this product, do not take more than directed.

Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless
  • symptoms do not get better within 7 days or are accompanied by fever
  • 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

  • shake well before use
  • use dose cup or tablespoon (TBSP)
  • do not exceed 6 doses per 24 hours
adults and children 12 years and over 30 ml (2 TBSP) every 4 hours
children 4 to under 12 years ask a doctor
children under 4 years do not use

Other information

  • each tablespoon contains: potassium 5 mg, sodium 49 mg
  • store at room temperature

Inactive ingredients

acesulfame potassium, carboxymethylcellulose sodium, citric acid, disodium EDTA, FD&C Blue No. 1, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate dihydrate, sorbitol

Questions?

1-800-873-8276

Dist. by Procter & Gamble,
Cincinnati OH 45202.

www.vicks.com

PRINCIPAL DISPLAY PANEL - 295 ml Bottle Label

NEW

VICKS®
VapoSyrup™

Mint Splash™
Flavor

With Soothing
Vicks Vapors

SEVERE
CONGESTION
Head & Chest
Congestion Relief

Guaifenesin…Expectorant
Phenylephrine…Nasal Decongestant

10 FL OZ (295 ml)
See Drug Facts

Principle Display Panel - 295 ml Bottle Label

VICKS VAPOSYRUP 
guaifenesin and phenylephrine hydrochloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-681
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Guaifenesin (Guaifenesin) Guaifenesin 100 mg  in 15 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine 5 mg  in 15 mL
Product Characteristics
Color BLUE Score     
Shape Size
Flavor MENTHOL, SPEARMINT, WATERMELON Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:37000-681-10 295 mL in 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 07/14/2009

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 07/2009 The Procter & Gamble Manufacturing Company



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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