Guaiatussin AC

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredients (in each 5 mL teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

Codeine Phosphate, USP 10 mg

Guaifenesin, USP 100 mg

Purposes

OTC - PURPOSE SECTION

Cough Suppressant

Expectorant

Uses

INDICATIONS & USAGE SECTION

• 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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

• 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

SPL UNCLASSIFIED SECTION

• 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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

• cough lasts 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

SPL UNCLASSIFIED SECTION

ask a health professional before use.

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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

Directions

DOSAGE & ADMINISTRATION SECTION

• 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 over	2 teaspoonfuls
children 6 to under 12 years of age	1 teaspoonfuls
children under 6 years of age	Consult a doctor

Other information

SPL UNCLASSIFIED SECTION

• 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 away from heat.
• Store at room temperature 15°- 30°C (59°-86°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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?

SPL UNCLASSIFIED SECTION

Call 1-800-932-5676, 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.

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AKORN

NDC 50383-087-16

Guaiatussin AC

Sugar-Free

• Expectorant
• Cough Suppresant

Each teaspoonful (5 mL) contains

Guaifenesin ……………. 100 mg

Codeine Phosphate…….. 10 mg

Alcohol………………….... 3.5% v/v

Distributed by:

Akorn Operating Company LLC

Gurnee, IL 60031

16 fl oz (473 mL)

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

• Guaiatussin AC Sugar Free
• guaifenesin and codeine phosphate
• CODEINE PHOSPHATE
• CODEINE ANHYDROUS
• GUAIFENESIN
• ALCOHOL
• CARAMEL
• ANHYDROUS CITRIC ACID
• FD&C RED NO. 40
• GLYCERIN
• POLYETHYLENE GLYCOL 4000
• WATER
• SACCHARIN SODIUM
• SODIUM BENZOATE
• SORBITOL

NDC Codes#

Ingredients#

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DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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Source XML

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Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 367 matching rows.

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Matched openFDA labels page 1 of 1 · 1 matching rows.

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