CODEINE PHOSPHATE AND GUAIFENESIN- codeine phosphate and guaifenesin liquid 
Bishop Pharma, LLC

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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Codeine Phosphate and Guaifenesin

CV

Active ingredients (in each teaspoonful (5 mL))

Codeine phosphate USP 10 mg

Guaifenesin USP 100 mg

Purpose

Antitussive (Cough Suppressant)

Expectorant

Uses

Warnings

Ask your Doctor if:

When using this product

Stop use and ask a doctor if

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

Adults and children 12 years of age and over:

2 tsp (10 mL) every 4 hours, or as directed by a doctor.

Children 6 to under 12 years of age:

1 tsp (5 mL) every 4 hours, or as directed by a doctor.

Children under 6 years of age:

Consult a doctor.

Other information

Store at controlled room temperature 20° to 25°C (68° to 77°F)

Inactive ingredients

Cherry flavor, citric acid, ededate disodium, FD&C red #40, glycerin, maltodextrin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose

Question or Comments
Please call 1-888-514-4727

Marketed by: Bishop Pharma, LLC
Pompano, FL 33069

PRINCIPAL DISPLAY PANEL

This is an image of the label for Cheratussin AC.
CODEINE PHOSPHATE AND GUAIFENESIN 
codeine phosphate and guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70861-1107
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70861-1107-1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/28/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34111/28/2018
Labeler - Bishop Pharma, LLC (080314584)

Revised: 1/2020
Document Id: 213086b4-4a1c-4eba-ba18-1d314d5cb139
Set id: c21b283a-a3ec-4e4d-9655-6f34aac575eb
Version: 2
Effective Time: 20200121
 
Bishop Pharma, LLC