Guaifed

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (200 mg)

Inactive Ingredients

Sucralose Menthol Methylparaben Propylene Glycol Water Sodium Citrate Citric Acid

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-07-01

Medication Information

Warnings and Precautions

Warnings

Do not use: if you ever had an allergic reaction to any of the ingredients in this product

Ask a doctor before use if you have

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

Indications and Usage

Uses:

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

Dosage and Administration

Directions

take every 4 hours as needed, or as directed by doctor
do not take more than 6 doses in 24 hours
do not exceed recommended dose

Age	Dose
adults and children 12 years and over	10 mL to 20 mL (2 to 4 teaspoonfuls)
children under 12 years of age	ask a doctor

Description

Active Ingredients: (per 10ml= 2 teaspoonfuls) Purpose Guaifenesin 200 mg ................................................................... Expectorant

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 50566-9

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.

Section 51727-6

Inactive Ingredients:

Artificial and natural cherry flavor, citric acid, menthol, Methylparaben, Propylene glycol, Propylparaben, purified water, sodium citrate, sucralose

Section 51945-4

Section 53413-1

Questions or Comments?305-592-9216 or [email protected]

Section 53414-9

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

Section 55105-1

Purpose

Expectorant

Section 55106-9

Active Ingredients:(per 10ml= 2 teaspoonfuls) Purpose

Guaifenesin 200 mg ................................................................... Expectorant

Section 60561-8

Other information

• TAMPER - EVIDENT FEATURE: Do not use if foil seal over bottle opening is torn, broken or missing.

• each 10 mL contains: Sodium 20 mg

• store at room temperature 15° - 30°C (59° - 86°F).

• Protect from freezing

• Protect from light

Structured Label Content

Indications and Usage (34067-9)

Uses:

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

Dosage and Administration (34068-7)

Directions

take every 4 hours as needed, or as directed by doctor
do not take more than 6 doses in 24 hours
do not exceed recommended dose

Age	Dose
adults and children 12 years and over	10 mL to 20 mL (2 to 4 teaspoonfuls)
children under 12 years of age	ask a doctor

Warnings and Precautions (34071-1)

Warnings

Do not use: if you ever had an allergic reaction to any of the ingredients in this product

Ask a doctor before use if you have

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

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 50566-9 (50566-9)

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.

Section 51727-6 (51727-6)

Inactive Ingredients:

Artificial and natural cherry flavor, citric acid, menthol, Methylparaben, Propylene glycol, Propylparaben, purified water, sodium citrate, sucralose

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or Comments?305-592-9216 or [email protected]

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Expectorant

Section 55106-9 (55106-9)

Active Ingredients:(per 10ml= 2 teaspoonfuls) Purpose

Guaifenesin 200 mg ................................................................... Expectorant

Section 60561-8 (60561-8)

Other information

• TAMPER - EVIDENT FEATURE: Do not use if foil seal over bottle opening is torn, broken or missing.

• each 10 mL contains: Sodium 20 mg

• store at room temperature 15° - 30°C (59° - 86°F).

• Protect from freezing

• Protect from light

Advanced Ingredient Data

[{"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "200", "strengthDenominator": "10", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses: Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.", "34068-7": "Directions take every 4 hours as needed, or as directed by doctor do not take more than 6 doses in 24 hours do not exceed recommended dose Age Dose adults and children 12 years and over 10 mL to 20 mL (2 to 4 teaspoonfuls) children under 12 years of age ask a doctor", "34071-1": "Warnings Do not use: if you ever had an allergic reaction to any of the ingredients in this product Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) cough that last or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50566-9": "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.", "51727-6": "Inactive Ingredients: Artificial and natural cherry flavor, citric acid, menthol, Methylparaben, Propylene glycol, Propylparaben, purified water, sodium citrate, sucralose", "53413-1": "Questions or Comments? 305-592-9216 or info@aldamapharm.com", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Purpose Expectorant", "55106-9": "Active Ingredients: (per 10ml= 2 teaspoonfuls) Purpose Guaifenesin 200 mg ................................................................... Expectorant", "60561-8": "Other information • TAMPER - EVIDENT FEATURE: Do not use if foil seal over bottle opening is torn, broken or missing. • each 10 mL contains: Sodium 20 mg • store at room temperature 15° - 30°C (59° - 86°F). • Protect from freezing • Protect from light"}