Guaifenesin

Cardinal Health

Guaifenesin Oral Solution 300 mg/15 ml

FULL PRESCRIBING INFORMATION: CONTENTS*

• Drug Information
• Active ingredient
• Purpose
• Keep Out of Reach of Children
• Guaifenesin Uses
• Warnings
• Directions
• Inactive ingredients
• How Supplied
• Storage
• Principal Display Panel
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Drug Information

Guaifenesin Oral Solution USP

Expectorant

Sugar Free/ Alcohol Free

Active ingredient

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

Purpose

Expectorant

Keep Out of Reach of Children

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

Guaifenesin Uses

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

Warnings

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

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.

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

Directions

Follow dosage below or use as directed by a physician, do not take more than 6 doses in any 24-hour period.

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

How Supplied

Guaifenesin Oral Solution USP is a red, raspberry flavored solution supplied in the following oral dosage forms: NDC 0121-0744-04 (4 fl oz bottle), NDC 0121-0744-08 (8 fl oz bottle), NDC 0121-0744-16 (16 fl oz bottle), NDC 0121-1744-05 (unit dose cups of 5 mL, 10 x 10's), NDC 0121-1744-10 (unit dose cups of 10 mL, 10 x 10's), and NDC 0121-1744-15 (unit dose cups of 15 mL, 10 x 10's).

Storage

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

Pharmaceutical Associates, Inc.

Breenville, SC 29605

R06/06

Principal Display Panel

Guaifenesin Oral Solution USP

200 mg/10 mL

5 Cups

Principal Display Panel

Guaifenesin Oral Solution USP

300 mg/15 mL

5 Cups