FDA Label for Guaifenesin And Dextromethorphan Hbr
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USES
- WARNINGS
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - 14 EXTENDED-RELEASE TABLET BLISTER PACK CARTON
Guaifenesin And Dextromethorphan Hbr Product Label
The following document was submitted to the FDA by the labeler of this product Kroger Company. 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 THE KROGER CO.
CINCINNATI, OHIO 45202
Otc - Purpose
Active ingredients (in each extended-release tablet) | Purposes |
---|---|
Dextromethorphan HBr 60 mg | Cough suppressant |
Guaifenesin 1,200 mg | Expectorant |
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help you get to sleep
Warnings
Do not use
- for children under 12 years of age
- 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
- 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
- cough lasts more than 7 days, comes back, or occurs with 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 extended-release 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: 1 extended-release tablet every 12 hours; not more than 2 extended-release 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, colloidal silicon dioxide, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone (K-30), stearic acid
Questions?
1-800-632-6900
You may also report side effects to this phone number.
Principal Display Panel - 14 Extended-Release Tablet Blister Pack Carton
COMPARE TO the active ingredients of
MAXIMUM STRENGTH Mucinex® DM
NDC 30142-963-14
Kroger®
OUR PHARMACIST RECOMMENDED
Maximum Strength
Mucus Relief
ER DM - Max
Guaifenesin 1200 mg &
Dextromethorphan HBr 60 mg
Extended-Release
Tablets
EXPECTORANT &
COUGH SUPPRESSANT
12
Hour
- Controls Cough
- Thins & Loosens Mucus
- Immediate & Extended Release
14 EXTENDED-RELEASE
TABLETS
* Please review the disclaimer below.