CODEINE GUAIFENESIN- codeine phosphate, guaifenesin solution 
Leading 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 GUAIFENESIN ORAL SOLUTION 10-100 mg/5 mL

Drug Facts

Active Ingredients                                                              Purpose

(in each teaspoonful (5 mL))

Codeine Phosphate USP 10 mg ................... Antitussive

Guaifenesin USP 100 mg ........................... Expectorant

Uses

Warnings

Ask your doctor before use if

  • you have a persistent cough, this may be a sign of a serious condition
  • you have a persistent cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • you have a cough that is accompanied by excessive phlegm (mucus)
  • you have chronic pulmonary disease or shortness of breath
  • giving to a child who is taking other drugs

When using this product

  • giving a higher dose than recommended by a doctor could result in serious side effects for your child. A special measuring device should be  used to give an accurate dose of this product to children under 6 years of age.
  • may cause or aggravate constipation

Stop use and ask a doctor if

  • symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache. These may be symptoms of a serious condition.

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

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.

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 15°-30°C (59°-86°F).

Inactive ingredients

Cherry Flavor, Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol

Manufactured For:

Leading Pharma, LLC

Fairfield, NJ 07004

Rev. 07/2019

containerlable120ml

containerlable473ml

CODEINE GUAIFENESIN 
codeine phosphate, guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69315-248
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69315-248-48473 mL in 1 BOTTLE; Type 0: Not a Combination Product12/19/2019
2NDC:69315-248-12120 mL in 1 BOTTLE; Type 0: Not a Combination Product12/19/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/19/2019
Labeler - Leading Pharma, LLC (079575060)
Registrant - Leading Pharma, LLC (079575060)
Establishment
NameAddressID/FEIBusiness Operations
Woodfield Pharmaceuticals, LLC079398730manufacture(69315-248)

Revised: 1/2020
Document Id: 4387821a-24d9-497c-bc91-b298e9e934d7
Set id: f1381589-f187-4504-8e12-7acef0e81730
Version: 4
Effective Time: 20200110
 
Leading Pharma, LLC