Sda-tussin 563

Sda-tussin 563
SPL v1
SPL
SPL Set ID 2a444cc8-96be-9432-e063-6394a90a1b63
Route
ORAL
Published
Effective Date 2024-12-01
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 Menthol Methylparaben Propylene Glycol Propylparaben Water Sodium Citrate Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-01
Description

In each 5 mL Guaifenesin - 100 mg

Medication Information

Warnings and Precautions

Warnings

Ask a doctor before use if you have

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

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompnaied by fever, rash, or persistent headache. These could be signs of a serious condition.

Indications and Usage

Uses

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

Directions

  • Do not take more tha 6 doses in any 24 hour period
  • Measure only with dosing cup provided
  • mL- mililiters
  • Adults and children over 12 years of age: take 2 teaspoonfuls (10 mL) every 4 hours as needed or as directed by a doctor
  • Children under 12 years of age: Do not use
Description

In each 5 mL Guaifenesin - 100 mg

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 51727-6

Inactive ingredients: cherry flavor, citric acid, FD&C red #40, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Section 51945-4

Section 53413-1

Questions or comments? 1-203-861-0005

Section 53414-9

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

Section 55105-1

Purpose

Expectorant

Section 55106-9

In each 5 mL

Guaifenesin - 100 mg

Structured Label Content

Indications and Usage (34067-9)

Uses

  • helps loosen phlegm (mucus)
  • helps thin bronchial secretions to make coughs more productive
Dosage and Administration (34068-7)

Directions

  • Do not take more tha 6 doses in any 24 hour period
  • Measure only with dosing cup provided
  • mL- mililiters
  • Adults and children over 12 years of age: take 2 teaspoonfuls (10 mL) every 4 hours as needed or as directed by a doctor
  • Children under 12 years of age: Do not use
Warnings and Precautions (34071-1)

Warnings

Ask a doctor before use if you have

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

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompnaied by fever, rash, or persistent headache. These could be signs of a serious condition.

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 51727-6 (51727-6)

Inactive ingredients: cherry flavor, citric acid, FD&C red #40, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? 1-203-861-0005

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)

In each 5 mL

Guaifenesin - 100 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:04.362138 · Updated: 2026-03-14T23:06:23.767952