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 teaspoonfuls

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.

Distributed By:

Cardinal Health

Dublin, OH 43017

LC2838411118

Package/Label Principal Display Panel

Guaiatussin AC CV

5 Cups

Delivers 5 mL

Bag label
GUAIATUSSIN AC  SUGAR FREE
guaifenesin and codeine phosphate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-9627(NDC:50383-087)
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorCHERRY (artificial cherry flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-9627-55 in 1 BAG09/08/2010
15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01209/08/2010
Labeler - Cardinal Health 107, LLC (118546603)

Revised: 11/2023
Document Id: 6a8d7267-cfa3-41e9-b66c-96be237681b7
Set id: 375605cc-b2e5-4da5-9262-1aba3fa381e1
Version: 2
Effective Time: 20231115
 
Cardinal Health 107, LLC