Guaiatussin AC by Cardinal Health 107, LLC Drug Facts

Guaiatussin AC by

Drug Labeling and Warnings

Guaiatussin AC by is a Otc medication manufactured, distributed, or labeled by Cardinal Health 107, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GUAIATUSSIN AC SUGAR FREE- guaifenesin and codeine phosphate liquid 
Cardinal Health 107, LLC

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Drug Facts

Active ingredients (in each 5 mL teaspoonful)

Codeine Phosphate, USP 10 mg

Guaifenesin, USP 100 mg

Purposes

Cough Suppressant

Expectorant

Keep Out of Reach of Children

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

Warnings

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 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 preparations 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 over:

  2 teaspoonfuls

• children 6 to under 12 years of age:

  1 teaspoonful

• children under 6 years of age:

  Consult 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 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 1-800-932-5676, 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.

Rev. 087:05 06/22

Generic Section

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only.

Distributed By:

Cardinal Health

Dublin, OH 43017

LC2838410424

Principal Display Panel

GUAIATUSSIN AC

5 CUPS

GUAIATUSSIN AC  SUGAR FREE
guaifenesin and codeine phosphate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55154-9627(NDC: 50383-087)
Route of Administration	ORAL	DEA Schedule	CV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)	CODEINE PHOSPHATE	10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
CARAMEL (UNII: T9D99G2B1R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY (artificial cherry flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55154-9627-5	5 in 1 BAG	09/08/2010	10/31/2023
1		5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	09/08/2010	10/31/2023

Labeler - Cardinal Health 107, LLC (118546603)

Revised: 9/2024

Document Id: f5105ea9-8ed1-4023-8be9-7477cf0735ee

34390-5

Set id: 375605cc-b2e5-4da5-9262-1aba3fa381e1

Version: 3

Effective Time: 20240905