Other
Drug Facts
TAMPER EVIDENT: Do not use if printed shrinkband is broken or missing.
DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202
Vicks Formula 44dm Liquid
FDA Label NDC 69423-810
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 Formula 44dm (NDC 69423-810). 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 ingredient (in each 15 ml), purpose, uses, otc - do not use, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each 15 Ml)
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Purpose
Cough suppressant
Expectorant
Uses
- temporarily relieves cough due to minor throat and bronchial irritation associated with a cold
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
Otc - Do Not Use
Do not useif 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
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
- a sodium-restricted diet
Stop Use And Ask A Doctor If
cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
• take only as directed
• only use the dose cup provided
• do not exceed 6 doses per 24 hours
| adults and children 12 years and over | 30 mL every 4 hours |
| children 6 to under 12 years | 15 mL every 4 hours |
| children 4 to under 6 years | ask a doctor |
| children under 4 years | do not use |
Other Information
• each 15 mL contains:sodium 45 mg
• store at no greater than 25°C
Inactive Ingredients
citric acid, FD&C Red No. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum
Questions?
1-800-362-1683
Principal Display Panel - 354 Ml Bottle Label
VICKS ®
FORMULA 44™ DM
COUGH &
CHEST CONGESTION
Dextromethorphan HBr, Guaifenesin
Cough
Chest Congestion, Thins & Loosens Mucus
Non-Drowsy
12 FL OZ (354 ml)
448 (448)
* Please review the disclaimer below.
