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

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Guaifenesin

Hi-Tech Pharmacal Co., Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Each 5 mL (1 teaspoonful) contains:

Guaifenesin ................................................ 100 mg

Inactive ingredients

Acesulfame K, artificial cherry & vanilla flavor, aspartame, hypromellose, menthol, methylparaben, potassium sorbate, purified water. Citric acid may be used to adjust pH.

Purpose

Expectorant

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.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

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

How Supplied:

Guaifenesin Oral Solution is a clear viscous liquid with a slight cherry odor supplied in the following oral dosage forms: 5 mL unit dose, 10 mL unit dose, 15 mL unit dose in trays of 10 and 4 fl. oz. (118 mL) bottle

Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)

STORAGE

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

Questions or comments?

Call 1-800-262-9010.


Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701


Rev.063:00 10/10

MG #29850

Package/Label Principal Display Panel

Guaifenesin

Delivers 15 mL

NDC 50383-063-15

GUAIFENESIN ORAL SOLUTION

300 mg/15 mL

Sugar Free/Alcohol Free

EXPECTORANT

SEE INSERT

FOR INSTITUTIONAL USE ONLY

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

Rev. 063:00 10/10

Guaifenesin

Guaifenesin SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50383-063
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Guaifenesin GUAIFENESIN 100 mg

Inactive Ingredients

Ingredient Name Strength
ACESULFAME POTASSIUM
ASPARTAME
HYPROMELLOSE 2910 (4000 MPA.S)
MENTHOL
METHYLPARABEN
POTASSIUM SORBATE
water
ANHYDROUS CITRIC ACID

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 5 in 1 CUP, UNIT-DOSE
2 5 in 1 CUP, UNIT-DOSE
3 10 in 1 CUP, UNIT-DOSE
4 10 in 1 CUP, UNIT-DOSE
5 15 in 1 CUP, UNIT-DOSE
6 15 in 1 CUP, UNIT-DOSE
7 10 in 1 TRAY
8 NDC:50383-063-18 10 in 1 CASE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2012-03-07


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Be sure to consult your doctor before taking any medication!
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