drug facts

drug facts
SPL v1
SPL
SPL Set ID 18f4c0c4-4448-470c-bd82-8d6cd3f8cd71
Route
oral
Published
Effective Date 2017-08-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
guaifenesin (100 mg)
Inactive Ingredients
acesulfame potassium aspartame hypromellose, unspecified menthol, unspecified form methylparaben potassium sorbate water anhydrous citric acid

Identifiers & Packaging

Marketing Status
otc monograph final active Since 1996-01-01
Purpose

Expectorant

Description

Guaifenesin 100 mg

Medication Information

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus
Purpose

Expectorant

Directions
  • take every 4 hours
  • do not exceed 6 doses in 24 hours
adults & children 12 years and over 10 mL - 20 mL (2 - 4 teaspoonfuls)
children 6 years to under 12 years 5 mL - 10 mL (1 - 2 teaspoonfuls)
children 2 years to under 6 years 2.5 mL - 5 mL (½ - 1 teaspoonful)
children under 2 years ask a doctor
Other Information
  • Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)
  • store at room temperature 20-25°C (68-77°F).
  • keep tightly closed.
Inactive Ingredients

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

Description

Guaifenesin 100 mg

Questions Or Comments?

Call 1-800-899-3116, Mon-Thurs 9:00 am - 5:00 pm EST, Fri 9:00 am - 2:30 pm EST. Serious side effects associated with use of this product may be reported to this number.



Rev #063:05 10/11

Stop Use and Ask A Doctor If:
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts

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.

Active Ingredient (in Each 5 Ml)

Guaifenesin 100 mg

Ask A Doctor Before Use If You Have:
  • a cough that occurs with too much phlegm (mucus)
  • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Principal Display Panel 118 Ml Bottle Label

City of Austin Dept of Health

GUAIFENESIN

118ml

Date:

Name:

Dr.

TAKE AS DIRECTED.

1/1/01

123456

GUAIFENESIN 118ml NDC 76413-335-01

Batch: 123456

Lot: 123456

Exp: 1/1/01

AKORN

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

Structured Label Content

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus
Purpose

Expectorant

Directions
  • take every 4 hours
  • do not exceed 6 doses in 24 hours
adults & children 12 years and over 10 mL - 20 mL (2 - 4 teaspoonfuls)
children 6 years to under 12 years 5 mL - 10 mL (1 - 2 teaspoonfuls)
children 2 years to under 6 years 2.5 mL - 5 mL (½ - 1 teaspoonful)
children under 2 years ask a doctor
Other Information (Other information)
  • Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)
  • store at room temperature 20-25°C (68-77°F).
  • keep tightly closed.
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

Call 1-800-899-3116, Mon-Thurs 9:00 am - 5:00 pm EST, Fri 9:00 am - 2:30 pm EST. Serious side effects associated with use of this product may be reported to this number.



Rev #063:05 10/11

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts

These could be signs of a serious condition.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Guaifenesin 100 mg

Ask A Doctor Before Use If You Have: (Ask a doctor before use if you have:)
  • a cough that occurs with too much phlegm (mucus)
  • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Principal Display Panel 118 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label)

City of Austin Dept of Health

GUAIFENESIN

118ml

Date:

Name:

Dr.

TAKE AS DIRECTED.

1/1/01

123456

GUAIFENESIN 118ml NDC 76413-335-01

Batch: 123456

Lot: 123456

Exp: 1/1/01

AKORN

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:24.189326 · Updated: 2026-03-14T22:54:50.171645