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| Product NDC Code | 77333-360 | ||||
|---|---|---|---|---|---|
| Drug Name | Guaifenesin 400mg caplets |
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| Type | Brand | ||||
| Pharm Class | Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET | ||||
| RxCUI drug identifier | 359601 | ||||
| Application Number | M012 | ||||
| Labeler Name | Gendose Pharmaceuticals, LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT (IN EACH CAPLET) GUAIFENESIN 400MG
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DIRECTIONS ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER TAKE 1 CAPLET EVERY 4 HOURS WITH A FULL GLASS OF WATER WHILE SYMPTOMS PERSIST. CHILDREN UNDER 12 YEARS OF AGE DO NOT USE.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS CROSCARMELLOSE SODIUM, MAGNESIUM STEARATE, MALTODEXTRIN, STEARIC ACID, MICROCRYSTALLINE CELLULOSE, POVIDONE, SILICON DIOXIDE
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.USES HELPS LOOSEN PHLEGM (MUCUS) AND THIN BRONCHIAL SECRETIONS TO RID THE BRONCHIAL PASSAGEWAY OF BOTHERSOME MUCUS. HELPS MAKE COUGHS MORE PRODUCTIVE
Purpose
Information about the drug product’s indications for use.PURPOSE EXPECTORANT
Spl product data elements
Usually a list of ingredients in a drug product.GUAIFENESIN 400MG CAPLETS GUAIFENESIN CROSCARMELLOSE SODIUM MAGNESIUM STEARATE MALTODEXTRIN STEARIC ACID MICROCRYSTALLINE CELLULOSE POVIDONE SILICON DIOXIDE GUAIFENESIN GUAIFENESIN G400 CAPLET
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.01b LBL_Guaifenesin_NDC 77333-360-10
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.KEEP OUT OF REACH OF CHILDREN. IN CASE OF OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER (1-800-222-1222) IMMEDIATELY.
Storage and handling
Information about safe storage and handling of the drug product.OTHER INFORMATION STORE AT 25°C (77°F) EXCURSIONS BETWEEN 15° - 30° C (59° - 86°F) KEEP IN A DRY PLACE AND DO NOT EXPOSE TO HEAT
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNINGS ASK DOCTOR BEFORE USE IF YOU HAVE: PERSISTENT OR CHRONIC COUGH SUAH AS OCCURS WITH SMOKING, ASTHMA, CHRONIC BRONCHITIS OR EMPHASEMA (MUCUS) COUGH ACCOMPANIED BY EXCESSIVE PHLEGM WHEN USING THIS PRODUCT DO NOT EXCEED RECOMMENDED DOSAGE DO NOT USE FOR MORE THAN 7 DAYS STOP USE AND ASK A DOCTOR IS COUGH LASTS FOR MORE THAN 7 DAYS, RECURS, OR IS ACCOMPANIED BY FEVER, RASH, OR PERSISTENT HEADACHE. THESE COULD BE SIGNS OF A SERIOUS CONDITION. IF PREGNANT OR BREAST FEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API