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  5. Label Information: Berkley And Jensen Mucus Relief

FDA Label for Berkley And Jensen Mucus Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH EXTENDED-RELEASE BI-LAYER TABLET)
    2. PURPOSE
    3. USES
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. STOP USE AND ASK A DOCTOR IF
    7. IF PREGNANT OR BREAST-FEEDING,
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS OR COMMENTS?
    13. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Berkley And Jensen Mucus Relief Product Label

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

Active Ingredient (In Each Extended-Release Bi-Layer Tablet)



Guaifenesin 1200 mg


Purpose



Expectorant


Uses



  • •helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Do Not Use



  • •for children under 12 years of age

Ask A Doctor Before Use If You Have



  • •persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • •cough accompanied by too much phlegm (mucus)

Stop Use And Ask A Doctor If



  • •cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.

    These could be signs of a serious illness.


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 (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 the timing of meals
  • •adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.
  • •children under 12 years of age: do not use

Other Information



  • •store between 20°-25°C (68°-77°F)

Inactive Ingredients



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


Questions Or Comments?



1-800-934-1204


Package/Label Principal Display Panel



Compare to the active ingredient in Maximum Strength Mucinex®

MAXIMUM STRENGTH

MUCUS RELIEF

GUAIFENESIN EXTENDED-RELEASE TABLETS, 1200mg

EXPECTORANT

RELIEVES CHEST CONGESTION

THINS AND LOOSENS MUCUS

IMMEDIATE AND EXTENDED RELEASE

12 HOUR

ACTUAL SIZE

56 EXTENDED-RELEASE BI-LAYER TABLETS

mucus relief image - image 01

mucus relief image - image 01


* Please review the disclaimer below.