Guaifenesin

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (100 mg)

Inactive Ingredients

Acesulfame Potassium Fd&c Green No. 3 Fd&c Red No. 40 Hydroxyethyl Cellulose, Unspecified Water Sodium Benzoate Sodium Citrate, Unspecified Form Anhydrous Citric Acid

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH DRUG Active Since 2002-09-01

Medication Information

Dosage Forms and Strengths

Guaifenesin Oral Solution USP is a red, raspberry flavored solution supplied in the following oral dosage forms:

NDC 0121-0744-04: 4 fl oz (120 mL) bottle

NDC 0121-0744-08: 8 fl oz (237 mL) bottle

NDC 0121-0744-16: 16 fl oz (473 mL) bottle

NDC 0121-1744-05: 5 mL unit dose cup

NDC 0121-1744-00: Case contains 100 unit dose cups of 5 mL (0121-1744-05) packaged in 10 trays of 10 unit dose cups each.

NDC 0121-1488-10: 10 mL unit dose cup

NDC 0121-1488-00: Case contains 100 unit dose cups of 10 mL (0121-1488-10) packaged in 10 trays of 10 unit dose cups each.

NDC 0121-2232-15: 15 mL unit dose cup

NDC 0121-2232-00: Case contains 100 unit dose cups of 15 mL (0121-2232-15) packaged in 10 trays of 10 unit dose cups each.

Description

Each 5 mL (1 teaspoonful) contains:

Guaifenesin 100 mg

Uses

Helps loosen phlegm (mucus) and thin bronchial secretions to 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 right away.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Expectorant

SUGAR FREE / ALCOHOL FREE

Storage

Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). [See USP] Protect from light.

Directions

Follow dosage below or use as directed by a physician.

do not take more than 6 doses in any 24-hour period.

age	dose
adults and children 12 years and over	10 to 20 mL (2 to 4 teaspoonfuls) every 4 hours
children 6 years to under 12 years	5 to 10 mL (1 to 2 teaspoonfuls) every 4 hours
children 2 to under 6 years of age	2.5 to 5 mL (½ to 1 teaspoonful) every 4 hours
children under 2 years of age	consult a physician

Professional Note

Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

Inactive Ingredients

Acesulfame K, citric acid, FD&C Green No. 3, FD&C Red No. 40, flavoring, hydroxyethylcellulose, purified water, sodium benzoate and sodium citrate.

Sodium Content: 4 mg/5 mL

Stop Use and Ask A Doctor If

cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
you are hypersensitive to any of the ingredients.

Ask A Doctor Before Use If You Have

cough that occurs with too much phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Principal Display Panel 5 Ml Cup Label

Delivers 5 mL

NDC 0121-1744-05

G UAIFENESIN O RAL S OLUTION USP

100 mg/5 mL

Sugar Free/Alcohol Free

EXPECTORANT

Package Not Child-Resistant

PHARMACEUTICAL ASSOCIATES, INC.

GREENVILLE, SC 29605

SEE INSERT

Principal Display Panel 10 Ml Cup Label

Delivers 10 mL

NDC 0121-1488-10

G UAIFENESIN O RAL S OLUTION USP

200 mg/10 mL

Sugar Free/Alcohol Free

EXPECTORANT

Package Not Child-Resistant

PHARMACEUTICAL ASSOCIATES, INC.

GREENVILLE, SC 29605

SEE INSERT

Principal Display Panel 15 Ml Cup Label

Delivers 15 mL

NDC 0121-2232-15

G UAIFENESIN O RAL S OLUTION USP

300 mg/15 mL

Sugar Free/Alcohol Free

EXPECTORANT

Package Not Child-Resistant

PHARMACEUTICAL ASSOCIATES, INC.

GREENVILLE, SC 29605

SEE INSERT

Principal Display Panel 473 Ml Bottle Label

NDC 0121-0744-16

Quality ^®

Value

Guaifenesin Oral Solution USP

100 mg/5 mL

EXPECTORANT

Compare to the

active ingredient in

*Robitussin®

SUGAR FREE/ALCOHOL FREE

LOOSENS AND RELIEVES

CHEST CONGESTION

16 fl oz (473 mL)

Pharmaceutical

Associates, Inc.

Greenville, SC 29605

Structured Label Content

Uses (USES)

Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Dosage Forms and Strengths (34069-5)

Guaifenesin Oral Solution USP is a red, raspberry flavored solution supplied in the following oral dosage forms:

NDC 0121-0744-04: 4 fl oz (120 mL) bottle

NDC 0121-0744-08: 8 fl oz (237 mL) bottle

NDC 0121-0744-16: 16 fl oz (473 mL) bottle

NDC 0121-1744-05: 5 mL unit dose cup

NDC 0121-1744-00: Case contains 100 unit dose cups of 5 mL (0121-1744-05) packaged in 10 trays of 10 unit dose cups each.

NDC 0121-1488-10: 10 mL unit dose cup

NDC 0121-1488-00: Case contains 100 unit dose cups of 10 mL (0121-1488-10) packaged in 10 trays of 10 unit dose cups each.

NDC 0121-2232-15: 15 mL unit dose cup

NDC 0121-2232-00: Case contains 100 unit dose cups of 15 mL (0121-2232-15) packaged in 10 trays of 10 unit dose cups each.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Expectorant

SUGAR FREE / ALCOHOL FREE

Storage (STORAGE)

Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). [See USP] Protect from light.

Directions (DIRECTIONS)

Follow dosage below or use as directed by a physician.

do not take more than 6 doses in any 24-hour period.

age	dose
adults and children 12 years and over	10 to 20 mL (2 to 4 teaspoonfuls) every 4 hours
children 6 years to under 12 years	5 to 10 mL (1 to 2 teaspoonfuls) every 4 hours
children 2 to under 6 years of age	2.5 to 5 mL (½ to 1 teaspoonful) every 4 hours
children under 2 years of age	consult a physician

Description (DESCRIPTION)

Each 5 mL (1 teaspoonful) contains:

Guaifenesin 100 mg

Professional Note

Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

Inactive Ingredients

Acesulfame K, citric acid, FD&C Green No. 3, FD&C Red No. 40, flavoring, hydroxyethylcellulose, purified water, sodium benzoate and sodium citrate.

Sodium Content: 4 mg/5 mL

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
you are hypersensitive to any of the ingredients.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

cough that occurs with too much phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Principal Display Panel 5 Ml Cup Label (PRINCIPAL DISPLAY PANEL - 5 mL Cup Label)

Delivers 5 mL

NDC 0121-1744-05

G UAIFENESIN O RAL S OLUTION USP

100 mg/5 mL

Sugar Free/Alcohol Free

EXPECTORANT

Package Not Child-Resistant

PHARMACEUTICAL ASSOCIATES, INC.

GREENVILLE, SC 29605

SEE INSERT

Principal Display Panel 10 Ml Cup Label (PRINCIPAL DISPLAY PANEL - 10 mL Cup Label)

Delivers 10 mL

NDC 0121-1488-10

G UAIFENESIN O RAL S OLUTION USP

200 mg/10 mL

Sugar Free/Alcohol Free

EXPECTORANT

Package Not Child-Resistant

PHARMACEUTICAL ASSOCIATES, INC.

GREENVILLE, SC 29605

SEE INSERT

Principal Display Panel 15 Ml Cup Label (PRINCIPAL DISPLAY PANEL - 15 mL Cup Label)

Delivers 15 mL

NDC 0121-2232-15

G UAIFENESIN O RAL S OLUTION USP

300 mg/15 mL

Sugar Free/Alcohol Free

EXPECTORANT

Package Not Child-Resistant

PHARMACEUTICAL ASSOCIATES, INC.

GREENVILLE, SC 29605

SEE INSERT

Principal Display Panel 473 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label)

NDC 0121-0744-16

Quality ^®

Value

Guaifenesin Oral Solution USP

100 mg/5 mL

EXPECTORANT

Compare to the

active ingredient in

*Robitussin®

SUGAR FREE/ALCOHOL FREE

LOOSENS AND RELIEVES

CHEST CONGESTION

16 fl oz (473 mL)

Pharmaceutical

Associates, Inc.

Greenville, SC 29605

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"USES": "Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.", "34069-5": "Guaifenesin Oral Solution USP is a red, raspberry flavored solution supplied in the following oral dosage forms: NDC 0121-0744-04: 4 fl oz (120 mL) bottle NDC 0121-0744-08: 8 fl oz (237 mL) bottle NDC 0121-0744-16: 16 fl oz (473 mL) bottle NDC 0121-1744-05: 5 mL unit dose cup NDC 0121-1744-00: Case contains 100 unit dose cups of 5 mL (0121-1744-05) packaged in 10 trays of 10 unit dose cups each. NDC 0121-1488-10: 10 mL unit dose cup NDC 0121-1488-00: Case contains 100 unit dose cups of 10 mL (0121-1488-10) packaged in 10 trays of 10 unit dose cups each. NDC 0121-2232-15: 15 mL unit dose cup NDC 0121-2232-00: Case contains 100 unit dose cups of 15 mL (0121-2232-15) packaged in 10 trays of 10 unit dose cups each.", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Expectorant SUGAR FREE / ALCOHOL FREE", "STORAGE": "Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). [See USP] Protect from light.", "DIRECTIONS": "Follow dosage below or use as directed by a physician. do not take more than 6 doses in any 24-hour period. age dose adults and children 12 years and over 10 to 20 mL (2 to 4 teaspoonfuls) every 4 hours children 6 years to under 12 years 5 to 10 mL (1 to 2 teaspoonfuls) every 4 hours children 2 to under 6 years of age 2.5 to 5 mL (½ to 1 teaspoonful) every 4 hours children under 2 years of age consult a physician", "DESCRIPTION": "Each 5 mL (1 teaspoonful) contains: Guaifenesin 100 mg", "Professional Note": "Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).", "Inactive Ingredients": "Acesulfame K, citric acid, FD&C Green No. 3, FD&C Red No. 40, flavoring, hydroxyethylcellulose, purified water, sodium benzoate and sodium citrate. Sodium Content: 4 mg/5 mL", "Stop use and ask a doctor if": "cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. you are hypersensitive to any of the ingredients.", "Ask a doctor before use if you have": "cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema", "PRINCIPAL DISPLAY PANEL - 5 mL Cup Label": "Delivers 5 mL NDC 0121-1744-05 G UAIFENESIN O RAL S OLUTION USP 100 mg/5 mL Sugar Free/Alcohol Free EXPECTORANT Package Not Child-Resistant PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 SEE INSERT", "PRINCIPAL DISPLAY PANEL - 10 mL Cup Label": "Delivers 10 mL NDC 0121-1488-10 G UAIFENESIN O RAL S OLUTION USP 200 mg/10 mL Sugar Free/Alcohol Free EXPECTORANT Package Not Child-Resistant PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 SEE INSERT", "PRINCIPAL DISPLAY PANEL - 15 mL Cup Label": "Delivers 15 mL NDC 0121-2232-15 G UAIFENESIN O RAL S OLUTION USP 300 mg/15 mL Sugar Free/Alcohol Free EXPECTORANT Package Not Child-Resistant PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 SEE INSERT", "PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label": "NDC 0121-0744-16 Quality ® Value Guaifenesin Oral Solution USP 100 mg/5 mL EXPECTORANT Compare to the active ingredient in *Robitussin® SUGAR FREE/ALCOHOL FREE LOOSENS AND RELIEVES CHEST CONGESTION 16 fl oz (473 mL) Pharmaceutical Associates, Inc. Greenville, SC 29605"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information