Lodaat- Guaifenesin - Odaat 1200 Mg Caplets (83139-175)

SPL v1

SPL

SPL Set ID f61d3ae0-11eb-2a82-e053-2995a90a95da

Route

ORAL

Published

Effective Date 2023-03-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (1200 mg)

Inactive Ingredients

Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) Magnesium Stearate Microcrystalline Cellulose Sodium Starch Glycolate Type A Hypromellose, Unspecified

Identifiers & Packaging

Pill Appearance

Imprint: G;1200 Shape: oval Color: white Size: 21 mm Score: 1

Marketing Status

ANDA Active Since 2023-03-04

Description

GUAIFENESIN 1200MG

Purpose

EXPECTORANT

Medication Information

Purpose

EXPECTORANT

Description

GUAIFENESIN 1200MG

Uses

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

Section 50565-1

KEEP OUT OF REACH OF CHILDREN. IN CASE OF OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER (1-800-222-1222) IMMEDIATELY.

Section 51945-4

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.

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.

Questions?

CALL TOLL-FREE +1 630 852 7544

Other Information

STORE BETWEEN 20-25°C (68-77°F)

Inactive Ingredients

CARBOMER HOMOPOLYMER TYBE B, HYPROMELLOSE, MAGNESIUM STEARATE, MICROCRYSTALLINE CELLULOSE, SODIUM STARCH GLYCOLATE.

Active Ingredient (in Each Extended Release Bi Layer Tablet)

GUAIFENESIN 1200MG

Structured Label Content

Uses (USES)

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

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN. IN CASE OF OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER (1-800-222-1222) IMMEDIATELY.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

EXPECTORANT

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.

Directions (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.

Questions? (QUESTIONS?)

CALL TOLL-FREE +1 630 852 7544

Other Information (OTHER INFORMATION)

STORE BETWEEN 20-25°C (68-77°F)

Inactive Ingredients (INACTIVE INGREDIENTS)

CARBOMER HOMOPOLYMER TYBE B, HYPROMELLOSE, MAGNESIUM STEARATE, MICROCRYSTALLINE CELLULOSE, SODIUM STARCH GLYCOLATE.

Active Ingredient (in Each Extended Release Bi Layer Tablet) (ACTIVE INGREDIENT (IN EACH EXTENDED-RELEASE BI-LAYER TABLET))

GUAIFENESIN 1200MG

Advanced Ingredient Data

[{"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "1200", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)", "unii": "HHT01ZNK31", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A", "unii": "H8AV0SQX4D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USES": "HELPS LOOSEN PHLEGM (MUCUS) AND THIN BRONCHIAL SECRETIONS TO RID THE BRONCHIAL PASSAGEWAY OF BOTHERSOME MUCUS AND MAKE COUGHS MORE PRODUCTIVE", "50565-1": "KEEP OUT OF REACH OF CHILDREN. IN CASE OF OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER (1-800-222-1222) IMMEDIATELY.", "PURPOSE": "EXPECTORANT", "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.", "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.", "QUESTIONS?": "CALL TOLL-FREE +1 630 852 7544", "OTHER INFORMATION": "STORE BETWEEN 20-25°C (68-77°F)", "INACTIVE INGREDIENTS": "CARBOMER HOMOPOLYMER TYBE B, HYPROMELLOSE, MAGNESIUM STEARATE, MICROCRYSTALLINE CELLULOSE, SODIUM STARCH GLYCOLATE.", "ACTIVE INGREDIENT (IN EACH EXTENDED-RELEASE BI-LAYER TABLET)": "GUAIFENESIN 1200MG"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:36.933672 · Updated: 2026-03-14T23:01:06.342894