FDA Label for Guaifenesin And Dextromethorphan Hbr

View Indications, Usage & Precautions

ACTIVE INGREDIENTS (IN EACH EXTENDED-RELEASE TABLET)
PURPOSES
USES
WARNINGS
ASK A DOCTOR BEFORE USE IF YOU HAVE
WHEN USING THIS PRODUCT
STOP USE AND ASK A DOCTOR IF
PREGNANCY OR BREAST FEEDING
KEEP OUT OF REACH OF CHILDREN
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Guaifenesin And Dextromethorphan Hbr Product Label

The following document was submitted to the FDA by the labeler of this product Sun Pharmaceutical Industries, 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.

Active Ingredients (In Each Extended-Release Tablet)

Dextromethorphan HBr 60 mg

Guaifenesin 1200 mg

Purposes

Cough suppressant

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.

Pregnancy Or Breast Feeding

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 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

Package/Label Principal Display Panel

NDC 63304-110-14

Maximum Strength

Guaifenesin & Dextromethorphan HBr Extended-Release Tablets

1200 mg/60 mg

Expectorant & Cough Suppressant

12 Hour

• Controls Cough

• Thins and Loosens Mucus

• Immediate and Extended Release

14 Extended-Release Tablets

SUN PHARMA

spl-guai-dextro-label - image 01

NDC 63304-106-21