Drugplain

GUAIFENESIN - ODAAT 1200 MG 1200 mg/1

GUAIFENESIN · TABLET · LODAAT LLC

No Recall History
Plain English

GUAIFENESIN - ODAAT 1200 MG is a prescription tablet containing guaifenesin at 1200 mg/1, taken oral. Manufactured by LODAAT LLC.

Key Facts

Brand Name
GUAIFENESIN - ODAAT 1200 MG
Generic Name
GUAIFENESIN
NDC Code (Product)
83139-175
Manufacturer
LODAAT LLC
Strength
1200 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
HUMAN OTC DRUG
Application #
ANDA213420
Drug Class
Decreased Respiratory Secretion Viscosity [PE]; Expectorant [EPC]
Marketing Start
03/04/2023

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

dyspnoea548 reports
pneumonia516 reports
nausea468 reports
fatigue437 reports
pain420 reports
drug ineffective416 reports
diarrhoea391 reports
cough360 reports
off label use360 reports
headache356 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

USES HELPS LOOSEN PHLEGM (MUCUS) AND THIN BRONCHIAL SECRETIONS TO RID THE BRONCHIAL PASSAGEWAY OF BOTHERSOME MUCUS AND MAKE COUGHS MORE PRODUCTIVE

Dosage & Administration

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 OF AGE AND OVER: TAKE 1 TABLET EVERY 12 HOURS. DO NOT EXCEED 2 TABLETS IN 24 HOURS. CHILDREN UNDER 12 YEARS OF AGE: DO NOT USE.

Warnings

WARNINGS DO NOT USE FOR CHILDREN UNDER 12 YEARS OF AGE ASK DOCTOR BEFORE USE IF YOU HAVE: PERSISTENT OR CHRONIC COUGH SUCH AS OCCURS WITH SMOKING, ASTHMA, CHRONIC BRONCHITIS OR EMPHASEMA (MUCUS) COUGH ACCOMPANIED BY EXCESSIVE PHLEGM 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.

Frequently Asked Questions

What is GUAIFENESIN - ODAAT 1200 MG used for?

GUAIFENESIN - ODAAT 1200 MG contains GUAIFENESIN. It is a tablet taken oral. Consult your doctor for specific uses.

Is GUAIFENESIN - ODAAT 1200 MG a controlled substance?

GUAIFENESIN - ODAAT 1200 MG is not classified as a controlled substance by the DEA.

What is the generic name for GUAIFENESIN - ODAAT 1200 MG?

The generic name for GUAIFENESIN - ODAAT 1200 MG is GUAIFENESIN. There are 12 other brand versions of GUAIFENESIN.

What is the NDC code for GUAIFENESIN - ODAAT 1200 MG 1200 mg/1?

The NDC (National Drug Code) for GUAIFENESIN - ODAAT 1200 MG 1200 mg/1 is 83139-175, listed by LODAAT LLC.