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Guaifenesin and Codeine Phosphate

Dosage form: solution
Ingredients: Guaifenesin 100mg in 5mL, Codeine Phosphate 10mg in 5mL
Labeler: Pharmaceutical Associates, Inc.
NDC Code: 0121-0775

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.

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
  • 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 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
  • 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 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
  • Sodium Content: 5 mg/5 mL
  • Tamper evident: Do not use if seal under cap is broken or missing
  • Keep container closed and store away from heat
  • Store at 20°- 25°C (68°-77°F)

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 - 5 mL Cup Label

Delivers 5 mL
NDC 0121-1775-05
GUAIFENESIN AND
CODEINE PHOSPHATE
CV
ORAL SOLUTION USP
100 mg/10 mg per 5 mL
Expectorant / Cough Suppressant
Alcohol Free / Sugar Free

FOR INSTITUTIONAL USE ONLY

PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
SEE INSERT

A17750500

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 (Guaifenesin) Guaifenesin100 mg  in 5 mL
Codeine Phosphate (Codeine Anhydrous) Codeine Phosphate10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
citric acid monohydrate 
edetate disodium 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
glycerin 
menthol, unspecified form 
propylene glycol 
water 
sodium benzoate 
sodium citrate, unspecified form 
saccharin sodium 
sorbitol 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0121-0775-04118 mL in 1 BOTTLE
2NDC:0121-0775-16473 mL in 1 BOTTLE
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 (Guaifenesin) Guaifenesin100 mg  in 5 mL
Codeine Phosphate (Codeine Anhydrous) Codeine Phosphate10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
citric acid monohydrate 
edetate disodium 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
glycerin 
menthol, unspecified form 
propylene glycol 
water 
sodium benzoate 
sodium citrate, unspecified form 
saccharin sodium 
sorbitol 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0121-1775-0510 TRAY in 1 CASE
110 CUP, UNIT-DOSE in 1 TRAY
15 mL in 1 CUP, UNIT-DOSE
2NDC:0121-1775-1010 TRAY in 1 CASE
210 CUP, UNIT-DOSE in 1 TRAY
210 mL in 1 CUP, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34110/01/2006
Labeler - Pharmaceutical Associates, Inc. (044940096)
Establishment
NameAddressID/FEIOperations
Pharmaceutical Associates, Inc.097630693MANUFACTURE(0121-0775, 0121-1775)

Revised: 03/2016
 
Pharmaceutical Associates, Inc.

← See all Guaifenesin and Codeine Phosphate brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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