Guaifenesin Dm

SPL v8

SPL

SPL Set ID ff970fff-d1a3-4322-83b4-34e361431a1c

Route

ORAL

Published

Effective Date 2023-11-21

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (100 mg)

Inactive Ingredients

Anhydrous Citric Acid Fd&c Red No. 40 Glycerin Menthol Water Sodium Benzoate Sodium Citrate Saccharin Sodium Sucrose

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH DRUG Active Since 1992-07-01

Description

Non-Narcotic, Alcohol Free Expectorant/Cough Suppressant

Medication Information

Dosage and Administration

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 mL (2 teaspoonfuls) every 4 hours
children 6 years to under 12 years	5 mL (1 teaspoonful) every 4 hours
children 2 years to under 6 years	2.5 mL (1/2 teaspoonful) every 4 hours
children under 2 years	ask a doctor

Dosage Forms and Strengths

HOW SUPPLIED: Guaifenesin Syrup and Dextromethorphan is a red, cherry flavored syrup supplied in the following oral dosage forms:

NDC 0121-0638-04: 4 fl oz (118 mL) bottle

NDC 0121-0638-08: 8 fl oz (237 mL) bottle

NDC 0121-0638-16: 16 fl oz (473 mL) bottle

NDC 01210638-05: 5 mL unit dose cup

NDC 0121-0638-00: Case contains 100 unit dose cups of 5 mL (0121-0638-05) packaged in 10 trays of 10 unit dose cups each.

NDC 0121-1276-10: 10 mL unit dose cup

NDC 0121-1276-00: Case contains 100 unit dose cups of 10 mL (0121-1276-10) packaged in 10 trays of 10 unit dose cups each.

Description

Each 5 mL (1 teaspoonful) contains:
Guaifenesin	100 mg
Dextromethorphan Hydrobromide	10 mg

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

Section 42229-5

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).

Section 44425-7

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

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 50570-1

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Section 51727-6

Inactive Ingredients: Citric acid, FD&C Red No. 40, flavoring, glycerin, menthol, purified water, sodium benzoate, sodium citrate, sodium saccharin, and sucrose.

Sodium Content: 4 mg/5 mL

Section 53414-9

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

Section 55105-1

Non-Narcotic, Alcohol Free

Expectorant/Cough Suppressant

Manufactured By

Pharmaceutical Associates, Inc.

Greenville, SC 29605

www.paipharma.com

R11/16

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 118 Ml Bottle Label

NDC 0121-0638-04

NSN 6505-01-318-1565

Quality ®

Value

Guaifenesin-DM

100 mg/10 mg per 5 mL

EXPECTORANT/COUGH SUPPRESSANT

Compare to the

active ingredients in

*Robitussin ^®-DM

CONTROLS COUGHS

LOOSENS AND RELIEVES

CHEST CONGESTION

4 fl oz (118 mL)

Pharmaceutical

Associates, Inc.

Greenville, SC 29605

Principal Display Panel 237 Ml Bottle Label

NDC 0121-0638-08

Quality ®

Value

Guaifenesin-DM

100 mg/10 mg per 5 mL

EXPECTORANT/COUGH SUPPRESSANT

Compare to the

active ingredients in

*Robitussin ^®-DM

CONTROLS COUGHS

LOOSENS AND RELIEVES

CHEST CONGESTION

8 fl oz (237 mL)

Pharmaceutical

Associates, Inc.

Greenville, SC 29605

Principal Display Panel 473 Ml Bottle Label

NDC 0121-0638-16

Quality ®

Value

Guaifenesin-DM

100 mg/10 mg per 5 mL

EXPECTORANT/COUGH SUPPRESSANT

Compare to the

active ingredients in

*Robitussin ^®-DM

CONTROLS COUGHS

LOOSENS AND RELIEVES

CHEST CONGESTION

16 fl oz (473 mL)

Pharmaceutical

Associates, Inc.

Greenville, SC 29605

Principal Display Panel 5 Ml Unit Dose Cup Label

Delivers 5 mL

NDC 0121-0638-05

GUAIFENESIN SYRUP

and DEXTROMETHORPHAN

100 mg/10 mg per 5 mL

Package Not Child-Resistant

PHARMACEUTICAL ASSOCIATES, INC.

GREENVILLE, SC 29605

SEE INSERT

Principal Display Panel 10 Ml Unit Dose Cup Label

Delivers 10 mL

NDC 0121-1276-10

GUAIFENESIN SYRUP

and DEXTROMETHORPHAN

200 mg/20 mg per 10 mL

Package Not Child-Resistant

PHARMACEUTICAL ASSOCIATES, INC.

GREENVILLE, SC 29605

SEE INSERT

Structured Label Content

Uses (USES)

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

Dosage and Administration (34068-7)

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 mL (2 teaspoonfuls) every 4 hours
children 6 years to under 12 years	5 mL (1 teaspoonful) every 4 hours
children 2 years to under 6 years	2.5 mL (1/2 teaspoonful) every 4 hours
children under 2 years	ask a doctor

Dosage Forms and Strengths (34069-5)

HOW SUPPLIED: Guaifenesin Syrup and Dextromethorphan is a red, cherry flavored syrup supplied in the following oral dosage forms:

NDC 0121-0638-04: 4 fl oz (118 mL) bottle

NDC 0121-0638-08: 8 fl oz (237 mL) bottle

NDC 0121-0638-16: 16 fl oz (473 mL) bottle

NDC 01210638-05: 5 mL unit dose cup

NDC 0121-0638-00: Case contains 100 unit dose cups of 5 mL (0121-0638-05) packaged in 10 trays of 10 unit dose cups each.

NDC 0121-1276-10: 10 mL unit dose cup

NDC 0121-1276-00: Case contains 100 unit dose cups of 10 mL (0121-1276-10) packaged in 10 trays of 10 unit dose cups each.

Section 42229-5 (42229-5)

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).

Section 44425-7 (44425-7)

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

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 50570-1 (50570-1)

Section 51727-6 (51727-6)

Inactive Ingredients: Citric acid, FD&C Red No. 40, flavoring, glycerin, menthol, purified water, sodium benzoate, sodium citrate, sodium saccharin, and sucrose.

Sodium Content: 4 mg/5 mL

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Non-Narcotic, Alcohol Free

Expectorant/Cough Suppressant

Description (DESCRIPTION)

Each 5 mL (1 teaspoonful) contains:
Guaifenesin	100 mg
Dextromethorphan Hydrobromide	10 mg

Manufactured By (MANUFACTURED BY)

Pharmaceutical Associates, Inc.

Greenville, SC 29605

www.paipharma.com

R11/16

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 118 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label)

NDC 0121-0638-04

NSN 6505-01-318-1565

Quality ®

Value

Guaifenesin-DM

100 mg/10 mg per 5 mL

EXPECTORANT/COUGH SUPPRESSANT

Compare to the

active ingredients in

*Robitussin ^®-DM

CONTROLS COUGHS

LOOSENS AND RELIEVES

CHEST CONGESTION

4 fl oz (118 mL)

Pharmaceutical

Associates, Inc.

Greenville, SC 29605

Principal Display Panel 237 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label)

NDC 0121-0638-08

Quality ®

Value

Guaifenesin-DM

100 mg/10 mg per 5 mL

EXPECTORANT/COUGH SUPPRESSANT

Compare to the

active ingredients in

*Robitussin ^®-DM

CONTROLS COUGHS

LOOSENS AND RELIEVES

CHEST CONGESTION

8 fl oz (237 mL)

Pharmaceutical

Associates, Inc.

Greenville, SC 29605

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

NDC 0121-0638-16

Quality ®

Value

Guaifenesin-DM

100 mg/10 mg per 5 mL

EXPECTORANT/COUGH SUPPRESSANT

Compare to the

active ingredients in

*Robitussin ^®-DM

CONTROLS COUGHS

LOOSENS AND RELIEVES

CHEST CONGESTION

16 fl oz (473 mL)

Pharmaceutical

Associates, Inc.

Greenville, SC 29605

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

Delivers 5 mL

NDC 0121-0638-05

GUAIFENESIN SYRUP

and DEXTROMETHORPHAN

100 mg/10 mg per 5 mL

Package Not Child-Resistant

PHARMACEUTICAL ASSOCIATES, INC.

GREENVILLE, SC 29605

SEE INSERT

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

Delivers 10 mL

NDC 0121-1276-10

GUAIFENESIN SYRUP

and DEXTROMETHORPHAN

200 mg/20 mg per 10 mL

Package Not Child-Resistant

PHARMACEUTICAL ASSOCIATES, INC.

GREENVILLE, SC 29605

SEE INSERT

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 temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold", "34068-7": "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 mL (2 teaspoonfuls) every 4 hours children 6 years to under 12 years 5 mL (1 teaspoonful) every 4 hours children 2 years to under 6 years 2.5 mL (1/2 teaspoonful) every 4 hours children under 2 years ask a doctor", "34069-5": "HOW SUPPLIED: Guaifenesin Syrup and Dextromethorphan is a red, cherry flavored syrup supplied in the following oral dosage forms: NDC 0121-0638-04: 4 fl oz (118 mL) bottle NDC 0121-0638-08: 8 fl oz (237 mL) bottle NDC 0121-0638-16: 16 fl oz (473 mL) bottle NDC 01210638-05: 5 mL unit dose cup NDC 0121-0638-00: Case contains 100 unit dose cups of 5 mL (0121-0638-05) packaged in 10 trays of 10 unit dose cups each. NDC 0121-1276-10: 10 mL unit dose cup NDC 0121-1276-00: Case contains 100 unit dose cups of 10 mL (0121-1276-10) packaged in 10 trays of 10 unit dose cups each.", "42229-5": "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).", "44425-7": "STORAGE: Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F) [See USP]. Protect from light. ", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50570-1": "Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.", "51727-6": "Inactive Ingredients: Citric acid, FD&C Red No. 40, flavoring, glycerin, menthol, purified water, sodium benzoate, sodium citrate, sodium saccharin, and sucrose. Sodium Content: 4 mg/5 mL", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Non-Narcotic, Alcohol Free Expectorant/Cough Suppressant", "DESCRIPTION": "Each 5 mL (1 teaspoonful) contains: Guaifenesin 100 mg Dextromethorphan Hydrobromide 10 mg", "MANUFACTURED BY": "Pharmaceutical Associates, Inc. Greenville, SC 29605 www.paipharma.com R11/16", "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 - 118 mL Bottle Label": "NDC 0121-0638-04 NSN 6505-01-318-1565 Quality ® Value Guaifenesin-DM 100 mg/10 mg per 5 mL EXPECTORANT/COUGH SUPPRESSANT Compare to the active ingredients in *Robitussin ®- DM CONTROLS COUGHS LOOSENS AND RELIEVES CHEST CONGESTION 4 fl oz (118 mL) Pharmaceutical Associates, Inc. Greenville, SC 29605", "PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label": "NDC 0121-0638-08 Quality ® Value Guaifenesin-DM 100 mg/10 mg per 5 mL EXPECTORANT/COUGH SUPPRESSANT Compare to the active ingredients in *Robitussin ®- DM CONTROLS COUGHS LOOSENS AND RELIEVES CHEST CONGESTION 8 fl oz (237 mL) Pharmaceutical Associates, Inc. Greenville, SC 29605", "PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label": "NDC 0121-0638-16 Quality ® Value Guaifenesin-DM 100 mg/10 mg per 5 mL EXPECTORANT/COUGH SUPPRESSANT Compare to the active ingredients in *Robitussin ®- DM CONTROLS COUGHS LOOSENS AND RELIEVES CHEST CONGESTION 16 fl oz (473 mL) Pharmaceutical Associates, Inc. Greenville, SC 29605", "PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label": "Delivers 5 mL NDC 0121-0638-05 GUAIFENESIN SYRUP and DEXTROMETHORPHAN 100 mg/10 mg per 5 mL Package Not Child-Resistant PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 SEE INSERT", "PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label": "Delivers 10 mL NDC 0121-1276-10 GUAIFENESIN SYRUP and DEXTROMETHORPHAN 200 mg/20 mg per 10 mL Package Not Child-Resistant PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 SEE INSERT"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:22.681376 · Updated: 2026-03-14T23:05:04.083969