CODEINE PHOSPHATE AND GUAIFENESIN- codeine phosphate and guaifenesin liquid 
BioRamo, 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: BioRamo
Fort Lauderdale, FL 33309

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:54932-208
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:54932-208-85118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/17/2017
2NDC:54932-208-86237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/17/2017
3NDC:54932-208-81473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/17/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34101/17/2017
Labeler - BioRamo, LLC (968948443)

Revised: 1/2020
Document Id: f4c0b08e-e127-4515-b6ab-eead526def60
Set id: a22921e1-ce6d-433f-8565-7835f5388f54
Version: 2
Effective Time: 20200120
 
BioRamo, LLC