GUAIFENESIN AND CODEINE PHOSPHATE- guaifenesin and codeine phosphate solution 
Pharmaceutical Associates, 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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Guaifenesin and Codeine Phosphate

Drug Facts

Active ingredients in each 5 mL (teaspoonful)Purposes
Codeine Phosphate, USP 10 mgCough Suppressant
Guaifenesin, USP 100 mgExpectorant

Uses

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 for 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 preparation is not recommended for children under 2 years of age.

Directions

adults and children 12 years and over10 mL (2 teaspoonfuls)
children 6 to under 12 years of age5 mL (1 teaspoonful)
children under 6 years of ageConsult a doctor

Other information

Inactive ingredients

Citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin and sorbitol.

Questions or comments?

Call 1-800-845-8210 or visit paipharma.com

Serious side effects associated with use of this product may be reported to this number.

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 0121-0775-16

Guaifenesin and Codeine
Phosphate Oral Solution USP
CV

100 mg/10 mg per 5 mL

Expectorant / Cough Suppressant

Alcohol Free / Sugar Free

Each teaspoonful (5 mL) contains:
Guaifenesin, USP 100 mg
Codeine Phosphate, USP 10 mg

Dispense in a tight, light-resistant
container with a child-resistant closure.

DO NOT ACCEPT IF SEAL
AROUND CAP IS BROKEN OR MISSING

16 fl oz (473 mL)

pai
Pharmaceutical
Associates, Inc.

Greenville, SC 29605

Principal Display Panel - 473 mL Bottle Label

PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label

Delivers 10 mL

NDC 0121-1550-10

G UAIFENESIN AND

C ODEINE P HOSPHATE

O RAL S OLUTION USP

CV

200 mg/20 mg per 10 mL

Expectorant / Cough Suppressant

Alcohol Free / Sugar Free

FOR INSTITUTIONAL USE ONLY

PHARMACEUTICAL ASSOCIATES, INC.

GREENVILLE, SC 29605

SEE INSERT

A17751001

PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label

PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label - 1775

Delivers 10 mL

NDC 0121-1775-10

G UAIFENESIN AND
C ODEINE P HOSPHATE
O RAL S OLUTION USP

CV

200 mg/20 mg per 10 mL

Expectorant / Cough Suppressant
Alcohol Free / Sugar Free

FOR INSTITUTIONAL USE ONLY

PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
SEE INSERT

A17751000

Principal Display Panel - 10 mL Unit Dose Cup Label - 1775
GUAIFENESIN AND CODEINE PHOSPHATE 
guaifenesin and codeine phosphate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-0775
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0121-0775-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2006
2NDC:0121-0775-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2006
3NDC:0121-0775-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2006
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/01/2006
GUAIFENESIN AND CODEINE PHOSPHATE 
guaifenesin and codeine phosphate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-1775
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0121-1775-0010 in 1 CASE10/01/2006
110 in 1 TRAY
1NDC:0121-1775-055 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2NDC:0121-1775-1010 in 1 CASE10/01/2006
210 in 1 TRAY
210 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 finalpart34110/01/2006
GUAIFENESIN AND CODEINE PHOSPHATE 
guaifenesin and codeine phosphate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-1550
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0121-1550-0010 in 1 CASE10/01/2006
110 in 1 TRAY
1NDC:0121-1550-1010 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 finalpart34110/01/2006
Labeler - Pharmaceutical Associates, Inc. (044940096)
Establishment
NameAddressID/FEIBusiness Operations
Pharmaceutical Associates, Inc.097630693manufacture(0121-0775, 0121-1775, 0121-1550)

Revised: 12/2017
Document Id: 60a55dbd-cba5-3f21-e053-2991aa0a66c7
Set id: 88d0994c-4270-4408-8837-bd97510b2118
Version: 6
Effective Time: 20171218
 
Pharmaceutical Associates, Inc.