Guaifenesin description, usages, side effects, indications, overdosage, supplying and lots more!

Menu
Search

Guaifenesin

Cardinal Health

Guaifenesin Oral Solution 300 mg/15 ml


FULL PRESCRIBING INFORMATION: CONTENTS*




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.

age dose
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 to under 6 years of age 2.5 to 5 mL (1/2 to 1 teaspoonful) every 4 hours
children under 2 years of age consult a physician

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

Guaifenesin

Principal Display Panel

Guaifenesin Oral Solution USP

300 mg/15 mL

5 Cups

Guaifenesin

Guaifenesin

Guaifenesin LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55154-9425(NDC:0121-1744)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Guaifenesin GUAIFENESIN 200 mg

Inactive Ingredients

Ingredient Name Strength
ACESULFAME POTASSIUM
CITRIC ACID MONOHYDRATE
FD&C GREEN NO. 3
FD&C RED NO. 40
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)
water
SODIUM BENZOATE
SODIUM CITRATE

Product Characteristics

Color
RED

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 10 in 1 CUP
2 NDC:55154-9425-5 5 in 1 BAG

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-06-02


Guaifenesin

Guaifenesin LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55154-9428(NDC:0121-1744)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Guaifenesin GUAIFENESIN 300 mg

Inactive Ingredients

Ingredient Name Strength
ACESULFAME POTASSIUM
CITRIC ACID MONOHYDRATE
FD&C GREEN NO. 3
FD&C RED NO. 40
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)
water
SODIUM BENZOATE
SODIUM CITRATE

Product Characteristics

Color
RED

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 15 in 1 CUP
2 NDC:55154-9428-5 5 in 1 BAG

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-06-02


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.