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  5. Label Information: Dometuss-g

FDA Label for Dometuss-g

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. DO NOT GIVE THIS PRODUCT IF YOU HAVE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. STOP USING THIS PRODUCT AND ASK A DOCTOR IF
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. TAMPER EVIDENT
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. PRINCIPAL DISPLAY PANEL - 100 TABLET BOTTLE LABEL

Dometuss-g Product Label

The following document was submitted to the FDA by the labeler of this product Domel. 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

Do not take this product: for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor.


Otc - Purpose



Active ingredients (in each tablet)Purpose
Guaifenesin200 mgExpectorant
Dextromethorphan HBr20 mgCough Suppressant
Phenylephrine HCl10 mgNasal Decongestant

Uses



  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • temporarily reduces cough due to minor throat and bronchial irritation associated with a cold
  • calm the cough control center, and relieves coughing.
  • Temporarily relief nasal congestion due to the common cold
  • hay fever or other upper respiratory allergies
  • sinus congestion and pressure

Warnings



  • Do not exceed recommended dosage

    • If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor.


Do Not Use



  • if you are now taken a prescription Monoaminoxidase Inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions or Parkinson's disease), or for two weeks after stopping the MAOI drug; If you do not know if you are taking a prescription drug that contains an MAOI, ask a doctor or pharmacist before taking this product

Do Not Give This Product If You Have



  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

Ask A Doctor Before Use If You Have



  • liver disease
  • if you are taking the blood thinning drug warfarin.

Stop Using This Product And Ask A Doctor If



  • new symptoms occur
  • symptoms do not improve within 7 days or are accompanied by fever.
  • pain or fever persists or gets worse. These could be signs of a serious condition

Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Otc - Pregnancy Or Breast Feeding



If you are pregnant or breast-feeding, ask a health professional before use.


Directions



Do not take more than 6 doses in any 24 hours period.

AgeDose
adults and children 12 years of age and over1 tablets every 4 hours.
children 6 to 12 years of age1/2 tablet every 4 hours.
children under 6 years of ageConsult a doctor.

Other Information



  • store at room temperature 15°- 30°C (59° - 86°F).

Tamper Evident



Do not use if there is evidence of tampering.


Inactive Ingredients



Dicalcium phosphate, magnesium stearate, maltodextrin, mirocrystalline cellulose, povidone, silicon dioxide, stearic acid, talc.


Questions Or Comments?



Calle de Diego #488
San Juan P.R. 00924

Phone: 787-767-3246
For more information visit
www.domelpharma.com


Principal Display Panel - 100 Tablet Bottle Label



NDC 53809-250-01

DOMETUSS-G

DEXTROMETHORPHAN HBr/
PHENYLEPHRINE HCl / GUAIFENESIN

* Please review the disclaimer below.