FDA.reportPublic FDA data

Guaiatussin AC

Manufacturer
Cardinal Health 107, LLC
Effective date
2023-11-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:20:29

Label at a glance#

ProductGuaiatussin AC Sugar Free
Active ingredientCODEINE PHOSPHATE, GUAIFENESIN
Label structure9 sections

Indications and uses

• 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

Dosage and administration

• 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...

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.

Distributed By:

Cardinal Health

Dublin, OH 43017

LC2838411118

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Guaiatussin AC CV

5 Cups

Delivers 5 mL

Bag label
Bag label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-087-04ML - Milliliter50383-08729494081-d566-4f6d-8538-414cea30439812012-07-24
50383-087-05ML - Milliliter50383-087527380f2-ab5d-4c06-9067-7faccb7b4caf12013-12-02
50383-087-07ML - Milliliter50383-08741adca2b-ffe8-4268-9221-bbcfc9746c3412013-12-02
50383-087-10ML - Milliliter50383-087a0b09403-6e9e-405f-b8b2-1815a522ccc812013-12-02
50383-087-12ML - Milliliter50383-0877ef59b38-bc41-4d6b-866a-eddac3fec54112013-12-02
50383-087-16ML - Milliliter50383-087916d3d41-fe50-4fdf-bcd2-173e682bfafe12012-07-24

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55154-962755154-9627-5
50383-087

Ingredients#

Every source-derived ingredient row is available through these pages.

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

Name, UNII, Kind table
NameUNIIKind
CODEINE PHOSPHATEGSL05Y1MN6ACTIB
GUAIFENESIN495W7451VQACTIB
ALCOHOL3K9958V90MIACT
CARAMELT9D99G2B1RIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 40004R4HFI6D95IACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f5105ea9-8ed1-4023-8be9-7477cf0735ee375605cc-b2e5-4da5-9262-1aba3fa381e12024-09-05WarningsExact identifier
spl set id: 375605cc-b2e5-4da5-9262-1aba3fa381e1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.