Guaifenesin, Dextromethorphan Hydrobromide Tablets

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (400 mg) Dextromethorphan (20 mg)

Inactive Ingredients

Magnesium Stearate Maltodextrin Povidone K30 Hypromelloses Sodium Starch Glycolate Type A Polyethylene Glycol 400 Microcrystalline Cellulose Croscarmellose Sodium Silicon Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: ET16 Shape: oval Color: white Size: 16 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-01-13

Medication Information

Warnings and Precautions

KEEP OUT OF THE REACH OF CHILDREN,FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING

Indications and Usage

cough cold, allergic

Dosage and Administration

Description

FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING

Section 50565-1

KEEP OUT OF THE REACH OF CHILDREN

Section 51727-6

Colloidal Silicon Di oxide USP/NF, Hypromellose 5 [ Hydroxy propyl methyl cellulose - E5] USP, Hypromellose 15 Hydroxy propyl methylcellulose E-15 USP, Magnesium stearate. USP/NF, Maltodextrin USP/NF, Microcrystalline cellulose (PH-102) USP/NF, Polyethylene glycol 400 USP/NF, Polyvinyl pyrrolidone (PVPK 30) USP, Sodium starch glycolate Type-A USP/NF, Stearic acid powder

Section 51945-4

Section 55105-1

FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING

Structured Label Content

Indications and Usage (34067-9)

cough cold, allergic

Dosage and Administration (34068-7)

Warnings and Precautions (34071-1)

KEEP OUT OF THE REACH OF CHILDREN,FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING

Section 50565-1 (50565-1)

KEEP OUT OF THE REACH OF CHILDREN

Section 51727-6 (51727-6)

Colloidal Silicon Di oxide USP/NF, Hypromellose 5 [ Hydroxy propyl methyl cellulose - E5] USP, Hypromellose 15 Hydroxy propyl methylcellulose E-15 USP, Magnesium stearate. USP/NF, Maltodextrin USP/NF, Microcrystalline cellulose (PH-102) USP/NF, Polyethylene glycol 400 USP/NF, Polyvinyl pyrrolidone (PVPK 30) USP, Sodium starch glycolate Type-A USP/NF, Stearic acid powder

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING

Advanced Ingredient Data

[{"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE K30", "unii": "U725QWY32X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A", "unii": "H8AV0SQX4D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "400", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "cough cold, allergic", "34071-1": "KEEP OUT OF THE REACH OF CHILDREN,FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING", "50565-1": "KEEP OUT OF THE REACH OF CHILDREN", "51727-6": "Colloidal Silicon Di oxide USP/NF, Hypromellose 5 [ Hydroxy propyl methyl cellulose - E5] USP, Hypromellose 15 Hydroxy propyl methylcellulose E-15 USP, Magnesium stearate. USP/NF, Maltodextrin USP/NF, Microcrystalline cellulose (PH-102) USP/NF, Polyethylene glycol 400 USP/NF, Polyvinyl pyrrolidone (PVPK 30) USP, Sodium starch glycolate Type-A USP/NF, Stearic acid powder", "55105-1": "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"}

Guaifenesin, Dextromethorphan Hydrobromide Tablets

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information