Guaifenesin Oral Solution Usp

SPL v1

SPL

SPL Set ID 2fd702ea-3069-472c-b99e-c527f1375705

Route

ORAL

Published

Effective Date 2024-10-17

Document Type 34390-5 HUMAN OTC DRUG LABEL

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 2024-10-20

Description

Expectorant SUGAR FREE / ALCOHOL FREE

Purpose

Expectorant

Medication Information

Purpose

Expectorant

Description

Expectorant SUGAR FREE / ALCOHOL FREE

Uses

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

Section 42229-5

Expectorant

SUGAR FREE / ALCOHOL FREE

Directions

Follow dosage below or use as directed by a physician.

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

Age (yr)	Dose (ml)
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 years to under 6 years	2.5 to 5 ml (1 /2 to 1 teaspoonful) every 4 hours
children under 2 years	consult a physician

Generic Section

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).

Distributed by:

American Health Packaging

Columbus, OH 43217

R0624

Active Ingredient

(in each 5 mL Cup) Guaifenesin 100 mg
(in each 10 mL Cup) Guaifenesin 200 mg
(in each 15 mL Cup) Guaifenesin 300 mg

Other Information

Each 5 ml contains: sodium 4 mg.
Each 10 ml contains: sodium 8 mg.
Each 15 ml contains: sodium 12 mg.
Store at controlled room temperature between 20° to 25°C (68° to 77°F) [see USP]. Protect from light.
DO NOT USE IF SEAL IS BROKEN.
Guaifenesin Oral Solution is a red, raspberry flavored solution and is available in the following dosage forms:

5 ml unit-dose cups: 100 cups (10 x 10) NDC 60687-852-17

10 ml unit-dose cups: 100 cups (10 x 10) NDC 60687-863-56

15 ml unit-dose cups: 100 cups (10 x 10) NDC 60687-874-16

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.

Questions Or Comments?

Call 1-800-845-8210

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.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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

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

Package/label Principal Display Panel – 100 Mg Per 5 Ml – Label

Case NDC 60687- 852-17/Cup NDC 60687- 852-40

Guaifenesin

Oral Solution USP

Expectorant

100 mg per 5 ml

SUGAR FREE / ALCOHOL FREE

Raspberry Flavor

Usual Dosage: See attached Drug Facts.

Store at 20° to 25°C (68° to 77°F) [See USP]

Protect from light.

FOR INSTITUTIONAL USE ONLY

T0744C050624 R0624

Package/label Principal Display Panel – 200 Mg Per 10 Ml – Label

Case NDC 60687- 863-56/Cup NDC 60687- 863-42

Guaifenesin

Oral Solution USP

Expectorant

200 mg per 10 ml

Sodium Content: 8 mg/10 ml

SUGAR FREE / ALCOHOL FREE

Raspberry Flavor

Usual Dosage: See attached Drug Facts.

Store at 20° to 25°C (68° to 77°F) [See USP]

Protect from light.

FOR INSTITUTIONAL USE ONLY

T0744C100624 R0624

Package/label Principal Display Panel – 300 Mg Per 15 Ml – Label

Case NDC 60687- 874-16/Cup NDC 60687- 874-44

Guaifenesin

Oral Solution USP

Expectorant

300 mg per 15 ml

Sodium Content: 12 mg/15 ml

SUGAR FREE / ALCOHOL FREE

Raspberry Flavor

Usual Dosage: See attached Drug Facts.

Store at 20° to 25°C (68° to 77°F) [See USP]

Protect from light.

FOR INSTITUTIONAL USE ONLY

T0744C150624 R0624

Package/label Principal Display Panel – 100 Mg Per 5 Ml – Cup Lid

NDC 60687- 852-40

Guaifenesin

Oral Solution, USP

Expectorant

100 mg per 5 ml

Sugar Free/Alcohol Free

Delivers 5 mL

PROTECT FROM LIGHT.

See package Drug Facts insert for full

prescribing information and storage.

For Institutional Use Only.

American Health Packaging

Columbus, OH 43217

F0744C050624

Package/label Principal Display Panel – 200 Mg Per 10 Ml – Cup Lid

NDC 60687- 863-42

Guaifenesin

Oral Solution, USP

Expectorant

200 mg per 10 ml

Sodium Content: 8 mg/10 ml

Sugar Free/Alcohol Free

Delivers 10 mL

PROTECT FROM LIGHT.

See package Drug Facts insert for full

prescribing information and storage.

For Institutional Use Only.

American Health Packaging

Columbus, OH 43217

F0744C100624

Package/label Principal Display Panel – 300 Mg Per 15 Ml – Cup Lid

NDC 60687- 874-44

Guaifenesin

Oral Solution, USP

Expectorant

300 mg per 15 ml

Sodium Content: 12 mg/15 ml

Sugar Free/Alcohol Free

Delivers 15 mL

PROTECT FROM LIGHT.

See package Drug Facts insert for full

prescribing information and storage.

For Institutional Use Only.

American Health Packaging

Columbus, OH 43217

F0744C150624

Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Expectorant

SUGAR FREE / ALCOHOL FREE

Purpose

Expectorant

Directions

Follow dosage below or use as directed by a physician.

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

Age (yr)	Dose (ml)
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 years to under 6 years	2.5 to 5 ml (1 /2 to 1 teaspoonful) every 4 hours
children under 2 years	consult a physician

Generic Section

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).

Distributed by:

American Health Packaging

Columbus, OH 43217

R0624

Active Ingredient (Active ingredient)

(in each 5 mL Cup) Guaifenesin 100 mg
(in each 10 mL Cup) Guaifenesin 200 mg
(in each 15 mL Cup) Guaifenesin 300 mg

Other Information

Each 5 ml contains: sodium 4 mg.
Each 10 ml contains: sodium 8 mg.
Each 15 ml contains: sodium 12 mg.
Store at controlled room temperature between 20° to 25°C (68° to 77°F) [see USP]. Protect from light.
DO NOT USE IF SEAL IS BROKEN.
Guaifenesin Oral Solution is a red, raspberry flavored solution and is available in the following dosage forms:

5 ml unit-dose cups: 100 cups (10 x 10) NDC 60687-852-17

10 ml unit-dose cups: 100 cups (10 x 10) NDC 60687-863-56

15 ml unit-dose cups: 100 cups (10 x 10) NDC 60687-874-16

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.

Questions Or Comments? (Questions or comments?)

Call 1-800-845-8210

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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

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

Package/label Principal Display Panel – 100 Mg Per 5 Ml – Label (Package/Label Principal Display Panel – 100 mg per 5 mL – Label)

Case NDC 60687- 852-17/Cup NDC 60687- 852-40

Guaifenesin

Oral Solution USP

Expectorant

100 mg per 5 ml

SUGAR FREE / ALCOHOL FREE

Raspberry Flavor

Usual Dosage: See attached Drug Facts.

Store at 20° to 25°C (68° to 77°F) [See USP]

Protect from light.

FOR INSTITUTIONAL USE ONLY

T0744C050624 R0624

Package/label Principal Display Panel – 200 Mg Per 10 Ml – Label (Package/Label Principal Display Panel – 200 mg per 10 mL – Label)

Case NDC 60687- 863-56/Cup NDC 60687- 863-42

Guaifenesin

Oral Solution USP

Expectorant

200 mg per 10 ml

Sodium Content: 8 mg/10 ml

SUGAR FREE / ALCOHOL FREE

Raspberry Flavor

Usual Dosage: See attached Drug Facts.

Store at 20° to 25°C (68° to 77°F) [See USP]

Protect from light.

FOR INSTITUTIONAL USE ONLY

T0744C100624 R0624

Package/label Principal Display Panel – 300 Mg Per 15 Ml – Label (Package/Label Principal Display Panel – 300 mg per 15 mL – Label)

Case NDC 60687- 874-16/Cup NDC 60687- 874-44

Guaifenesin

Oral Solution USP

Expectorant

300 mg per 15 ml

Sodium Content: 12 mg/15 ml

SUGAR FREE / ALCOHOL FREE

Raspberry Flavor

Usual Dosage: See attached Drug Facts.

Store at 20° to 25°C (68° to 77°F) [See USP]

Protect from light.

FOR INSTITUTIONAL USE ONLY

T0744C150624 R0624

Package/label Principal Display Panel – 100 Mg Per 5 Ml – Cup Lid (Package/Label Principal Display Panel – 100 mg per 5 mL – Cup Lid)

NDC 60687- 852-40

Guaifenesin

Oral Solution, USP

Expectorant

100 mg per 5 ml

Sugar Free/Alcohol Free

Delivers 5 mL

PROTECT FROM LIGHT.

See package Drug Facts insert for full

prescribing information and storage.

For Institutional Use Only.

American Health Packaging

Columbus, OH 43217

F0744C050624

Package/label Principal Display Panel – 200 Mg Per 10 Ml – Cup Lid (Package/Label Principal Display Panel – 200 mg per 10 mL – Cup Lid)

NDC 60687- 863-42

Guaifenesin

Oral Solution, USP

Expectorant

200 mg per 10 ml

Sodium Content: 8 mg/10 ml

Sugar Free/Alcohol Free

Delivers 10 mL

PROTECT FROM LIGHT.

See package Drug Facts insert for full

prescribing information and storage.

For Institutional Use Only.

American Health Packaging

Columbus, OH 43217

F0744C100624

Package/label Principal Display Panel – 300 Mg Per 15 Ml – Cup Lid (Package/Label Principal Display Panel – 300 mg per 15 mL – Cup Lid)

NDC 60687- 874-44

Guaifenesin

Oral Solution, USP

Expectorant

300 mg per 15 ml

Sodium Content: 12 mg/15 ml

Sugar Free/Alcohol Free

Delivers 15 mL

PROTECT FROM LIGHT.

See package Drug Facts insert for full

prescribing information and storage.

For Institutional Use Only.

American Health Packaging

Columbus, OH 43217

F0744C150624

Advanced Ingredient Data

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"IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE, UNSPECIFIED FORM", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACESULFAME POTASSIUM", "unii": "23OV73Q5G9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C GREEN NO. 3", "unii": "3P3ONR6O1S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYETHYL CELLULOSE, UNSPECIFIED", "unii": "T4V6TWG28D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE, UNSPECIFIED FORM", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "200", "strengthDenominator": "10", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACESULFAME POTASSIUM", "unii": "23OV73Q5G9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C GREEN NO. 3", "unii": "3P3ONR6O1S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYETHYL CELLULOSE, UNSPECIFIED", "unii": "T4V6TWG28D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE, UNSPECIFIED FORM", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "300", "strengthDenominator": "15", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive", "42229-5": "Expectorant SUGAR FREE / ALCOHOL FREE", "Purpose": "Expectorant", "Directions": "Follow dosage below or use as directed by a physician. do not take more than 6 doses in any 24-hour period. Age (yr) Dose (ml) 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 years to under 6 years 2.5 to 5 ml (1 /2 to 1 teaspoonful) every 4 hours children under 2 years consult a physician", "Generic Section": "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). Distributed by: American Health Packaging Columbus, OH 43217 R0624", "Active ingredient": "(in each 5 mL Cup) Guaifenesin 100 mg (in each 10 mL Cup) Guaifenesin 200 mg (in each 15 mL Cup) Guaifenesin 300 mg", "Other Information": "Each 5 ml contains: sodium 4 mg. Each 10 ml contains: sodium 8 mg. Each 15 ml contains: sodium 12 mg. Store at controlled room temperature between 20° to 25°C (68° to 77°F) [see USP]. Protect from light. DO NOT USE IF SEAL IS BROKEN. Guaifenesin Oral Solution is a red, raspberry flavored solution and is available in the following dosage forms: 5 ml unit-dose cups: 100 cups (10 x 10) NDC 60687-852-17 10 ml unit-dose cups: 100 cups (10 x 10) NDC 60687-863-56 15 ml unit-dose cups: 100 cups (10 x 10) NDC 60687-874-16", "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.", "Questions or comments?": "Call 1-800-845-8210", "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.", "If pregnant or breast-feeding,": "ask a health professional before use.", "Keep out of reach of children.": "In case of overdose, get medical help or contact a Poison Control Center right away .", "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", "Package/Label Principal Display Panel – 100 mg per 5 mL – Label": "Case NDC 60687- 852 -17/Cup NDC 60687- 852 -40 Guaifenesin Oral Solution USP Expectorant 100 mg per 5 ml SUGAR FREE / ALCOHOL FREE Raspberry Flavor Usual Dosage: See attached Drug Facts. Store at 20° to 25°C (68° to 77°F) [See USP] Protect from light. FOR INSTITUTIONAL USE ONLY T0744C050624 R0624", "Package/Label Principal Display Panel – 200 mg per 10 mL – Label": "Case NDC 60687- 863 -56/Cup NDC 60687- 863 -42 Guaifenesin Oral Solution USP Expectorant 200 mg per 10 ml Sodium Content: 8 mg/10 ml SUGAR FREE / ALCOHOL FREE Raspberry Flavor Usual Dosage: See attached Drug Facts. Store at 20° to 25°C (68° to 77°F) [See USP] Protect from light. FOR INSTITUTIONAL USE ONLY T0744C100624 R0624", "Package/Label Principal Display Panel – 300 mg per 15 mL – Label": "Case NDC 60687- 874 -16/Cup NDC 60687- 874 -44 Guaifenesin Oral Solution USP Expectorant 300 mg per 15 ml Sodium Content: 12 mg/15 ml SUGAR FREE / ALCOHOL FREE Raspberry Flavor Usual Dosage: See attached Drug Facts. Store at 20° to 25°C (68° to 77°F) [See USP] Protect from light. FOR INSTITUTIONAL USE ONLY T0744C150624 R0624", "Package/Label Principal Display Panel – 100 mg per 5 mL – Cup Lid": "NDC 60687- 852 -40 Guaifenesin Oral Solution, USP Expectorant 100 mg per 5 ml Sugar Free/Alcohol Free Delivers 5 mL PROTECT FROM LIGHT. See package Drug Facts insert for full prescribing information and storage. For Institutional Use Only. American Health Packaging Columbus, OH 43217 F0744C050624", "Package/Label Principal Display Panel – 200 mg per 10 mL – Cup Lid": "NDC 60687- 863 -42 Guaifenesin Oral Solution, USP Expectorant 200 mg per 10 ml Sodium Content: 8 mg/10 ml Sugar Free/Alcohol Free Delivers 10 mL PROTECT FROM LIGHT. See package Drug Facts insert for full prescribing information and storage. For Institutional Use Only. American Health Packaging Columbus, OH 43217 F0744C100624", "Package/Label Principal Display Panel – 300 mg per 15 mL – Cup Lid": "NDC 60687- 874 -44 Guaifenesin Oral Solution, USP Expectorant 300 mg per 15 ml Sodium Content: 12 mg/15 ml Sugar Free/Alcohol Free Delivers 15 mL PROTECT FROM LIGHT. See package Drug Facts insert for full prescribing information and storage. For Institutional Use Only. American Health Packaging Columbus, OH 43217 F0744C150624"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:54.945166 · Updated: 2026-03-14T23:04:15.032207