Guaiatussin Ac
FDA Label NDC 50383-087

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Akorn Operating Company Llc for the product Guaiatussin Ac (NDC 50383-087). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (in each 5ml teaspoonful), purposes, use, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each 5Ml Teaspoonful)

Codeine Phosphate, USP 10 mg

Guaifenesin, USP 100 mg

Purposes

Cough Suppressant

Expectorant

Use

  • temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants
  • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive

Do Not Use

  • in adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, unless directed by a doctor.

Ask A Doctor Before Use If You Have

  • a cough with too much phlegm (mucus)
  • a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives, tranquilizers and drugs used for depression, especially monoamine oxidase inhibitors (MAOIs). These combinations may cause greater sedation (drowsiness) than is caused by the product used alone.

Stop Use And Ask A Doctor If

  • cough lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These can be signs of a serious condition.
  • may cause or aggravate constipation

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

  • Use of codeine-containing preparation is not recommended for children under 2 years of age

Directions

  • take every 4 hours
  • do not exceed 6 doses in 24 hours
  • a special measuring device should be used to give an accurate dose of this product to children under 6 years of age
  • giving a higher dose than recommended by a doctor can result in serious side effects for a child
    • adults and children 12 years and over2 teaspoonfuls
    children 6 to under 12 years of age1 teaspoonful
    children under 6 years of ageConsult a doctor

Other Information

  • each (5 mL) teaspoon contains: 1 mg sodium
  • Tamper evident: Do not use if seal under cap is broken or missing
  • Keep container closed and store away from heat
  • Store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients

alcohol 3.5% v/v, artificial cherry flavor, caramel, citric acid, FD&C red # 40, glycerin, polyethylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution.

Questions Or Comments?

Call 1-800-262-9010, Mon. - Thurs. 9:00 am thru 4:30 pm EST, Fri. 9:00 am thru 2:30 pm EST.

Serious side effects associated with use of this product may be reported to this number.

REV. 087:01 9/11

Package/Label Principal Display Panel

NDC 50383-087-16

Guaiatussin AC

Sugar-Free

CV

  • Expectorant
  • Cough Suppressant

    • Each teaspoonful (5 mL) contains

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

    Codeine Phosphate..................10 mg

    Alcohol.......................................3.5 % v/v

    Hi-Tech Pharmacal Co., Inc.

    Amityville, NY 11701

    16 fl oz (473 mL)

* Please review the disclaimer below.