CHERATUSSIN AC- codeine phosphate and guaifenesin liquid 
Preferred Pharmaceuticals, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Cheratussin® AC

CV

Active ingredients (in each 5 mL = 1 tsp)

Codeine phosphate, USP 10 mg

Guaifenesin, USP 100 mg

Purpose

Cough suppressant

Expectorant

Uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
calms the cough control center and relieves coughing

Warnings

Do not use

in a child under 2 years of age
if you or your child has a chronic pulmonary disease or shortness of breath
if your child is taking other drugs, unless directed by a doctor

Ask a doctor before use if you have

cough that occurs with excessive phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

When using this product constipation may occur or be aggravated

Stop use and ask a doctor if cough lasts more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

take every 4 hours
do not take more than 6 doses in any 24-hour period

adults and children 12 years and over

take 10 mL (2 tsp)

children 6 years to under 12 years

take 5 mL (1 tsp)

children 2 years to under 6 years

consult a doctor

children under 2 years

do not use

Attention: 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 could result in serious side effects for your child.

Other information

store at 15° to 30°C (59° to 86°F)

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive ingredients

alcohol, caramel, citric acid, FD&C red #40, flavor, glycerin, menthol racemic, purified water, saccharin sodium, sodium benzoate, sorbitol solution

Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 1/15 R7 8081202 1075

PRINCIPAL DISPLAY PANEL

Cheratussin AC Cough Suppressant Expectorant (CV)
CHERATUSSIN AC 
codeine phosphate and guaifenesin liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-9066(NDC:0603-1075)
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)  
MENTHOL (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color RED Score     
Shape Size
Flavor CHERRY Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68788-9066-1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 09/01/1996
Labeler - Preferred Pharmaceuticals, Inc (791119022)
Registrant - Preferred Pharmaceuticals, Inc (791119022)
Establishment
Name Address ID/FEI Business Operations
Preferred Pharmaceuticals, Inc 791119022 RELABEL(68788-9066)

Revised: 10/2015
Document Id: ae2f8a75-1a2a-45b3-9eed-3b0ba12f87ac
Set id: 532d83c7-7e01-4777-927c-cf01db6847e5
Version: 5
Effective Time: 20151030
 
Preferred Pharmaceuticals, Inc