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  5. Label Information: Maximum Strength Chest Congestion And Cough

FDA Label for Maximum Strength Chest Congestion And Cough

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. OTC - DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. OTC - STOP USE
    7. OTC - PREGNANCY OR BREAST FEEDING
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS OR COMMENTS?
    13. PRINCIPAL DISPLAY PANEL

Maximum Strength Chest Congestion And Cough Product Label

The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy, Inc.. 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


Otc - Purpose



Active ingredients (in each softgel)Purposes
Dextromethorphan HBr, USP 10 mgCough suppressant
Guaifenesin, USP 200 mgExpectorant

Uses



  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Otc - Do Not Use



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



  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Otc - Stop Use



Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by 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. In case of overdose, get medical help or contact a Poison Control Center right away.


Directions



  • do not take more than 12 softgels in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age
    • agedose
    adults and children 12 years and over2 softgels every 4 hours
    children under 12 yearsdo not use

Other Information



  • store at 20-25°C (68-77°F).
  • avoid excessive heat above 40°C (104°F).

Inactive Ingredients



FD&C Red-40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, special sorbitol, titanium dioxide


Questions Or Comments?



1-888-333-9792


Principal Display Panel



Compare to the active ingredients in Robitussin® Maximum

Strength Cough+Chest Congestion DM*

Maximum Strength

Cough + Chest Congestion DM

DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT
GUAIFENESIN/ EXPECTORANT

MAXIMUM STRENGTH

Relieves

cough
chest congestion
20 SOFTGELS



* Please review the disclaimer below.