Guaifenesin DM

Pharmaceutical Associates, Inc.

Maximum Strength Guaifenesin DM Non-Narcotic, Sugar and Alcohol Free Expectorant/Cough Suppressant

FULL PRESCRIBING INFORMATION: CONTENTS*

• Guaifenesin DM Uses
• Warnings
  • Ask a doctor before use if you have
  • Directions
  • Guaifenesin DM Other information
• Inactive ingredients
• Questions or comments?
• PRINCIPAL DISPLAY PANEL - 118 mL Label
  • PRINCIPAL DISPLAY PANEL - 5 mL Lid

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Guaifenesin DM Uses

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Warnings

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.

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.

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.

Directions

• shake well before using
• do not take more than 6 doses in any 24-hour period

  age	dose
  adults and children 12 years and over	10 mL (2 teaspoonsful) every 4 hours
  children 6 to under 12 years of age	5 mL (1 teaspoonful) every 4 hours
  children 2 to under 6 years of age	2.5 mL (1/2 teaspoonful) every 4 hours
  children under 2 years	consult a doctor

Other information

• each teaspoonful contains: sodium 4 mg
• store at 20° - 25°C (68° - 77°F)
• alcohol/sugar free
• red, cherry flavored solution supplied in the following oral dosage forms: NDC 0121-0809-04 (4 fl oz bottle), NDC 0121-0809-08 (8 fl oz bottle), NDC 0121-4809-05 (unit dose cups of 5 mL, packaged in trays of 10), and NDC 0121-4809-10 (unit dose cups of 10 mL, packaged in trays of 10).

Inactive ingredients

Acesulfame K, citric acid, FD&C Red No. 40, flavoring, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol and sucralose.

Questions or comments?

Call 1-800-845-8210. You may also report serious side effects to this phone number.

PRINCIPAL DISPLAY PANEL - 118 mL Label

NDC 0121-0809-04

Quality^®
Value

Maximum Strength

Guaifenesin DM

Cough & Chest
Congestion

DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)

ALCOHOL / SUGAR FREE
Relieves Cough /
Maximum Strength
Mucus Relief

4 fl oz (118 mL)

PRINCIPAL DISPLAY PANEL - 5 mL Lid

Delivers 5 mL
NDC 0121-4809-05

MAXIMUM STRENGTH
G UAIFENESIN DM

Guaifenesin (Expectorant)
Dextromethorphan HBr (Cough Suppressant)

200 mg/10 mg per 5 mL

Alcohol Free / Sugar Free

FOR INSTITUTIONAL USE ONLY
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
SEE INSERT