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  5. Label Information: Guaifenesin And Pseudoephedrine Hydrochloride

FDA Label for Guaifenesin And Pseudoephedrine Hydrochloride

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. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS?
    14. PRINCIPAL DISPLAY PANEL - 600 MG/60 MG TABLET BLISTER PACK CARTON

Guaifenesin And Pseudoephedrine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Ohm Laboratories 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

Distributed by:
Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512


Otc - Purpose



Active ingredients (in each extended-release tablet)Purposes

Guaifenesin 600 mg

Expectorant

Pseudoephedrine HCl 60 mg

Nasal Decongestant


Uses



  • •helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • •temporarily relieves nasal congestion due to:
    • •common cold
    • •hay fever
    • •upper respiratory allergies
    • •temporarily restores freer breathing through the nose
    • •promotes nasal and/or sinus drainage
    • •temporarily relieves sinus congestion and pressure

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



  • •heart disease
  • •high blood pressure
  • •thyroid disease
  • •diabetes
  • •trouble urinating due to an enlarged prostate gland
  • •persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • •cough accompanied by too much phlegm (mucus)

When Using This Product



  • •do not use more than directed

Stop Use And Ask A Doctor If



  • •you get nervous, dizzy, or sleepless
  • •symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness.

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 (1-800-222-1222).


Directions



  • •do not crush, chew, or break tablet
  • •take with a full glass of water
  • •this product can be administered without regard for timing of meals
  • •adults and children 12 years and older: 2 tablets every 12 hours; not more than 4 tablets in 24 hours
  • •children under 12 years of age: do not use

Other Information



  • •Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing.
  • •store between 20-25°C (68-77°F)

Inactive Ingredients



carbomer homopolymer type B; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF


Questions?



(1-800-406-7984)

You may also report side effects to this phone number.


Principal Display Panel - 600 Mg/60 Mg Tablet Blister Pack Carton



NDC 51660-071-18

†Compare To
the active ingredients of
Mucinex® D

ohm®

Guaifenesin 600 mg
& Pseudoephedrine HCl 60 mg
Extended-Release Tablets

Expectorant & Nasal Decongestant

12 Hour

* Please review the disclaimer below.