CODEINE-GUAIFENESIN- codeine phosphate and guaifenesin solution 
NuCare Pharmaceuticals,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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Codeine-Guaifenesin Oral Solution

Active ingredient

(in each teaspoonful (5 mL))
Codeine Phosphate USP 10 mg

Purpose

Antitussive

Active ingredient

(in each teaspoonful (5 mL))
Guaifenesin USP 100 mg

Purpose

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 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 15°-30°C (59°-86°F).

Inactive ingredients

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

Principal Display Panel

pdp

CODEINE-GUAIFENESIN 
codeine phosphate and guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-5173(NDC:58657-500)
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)  
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:68071-5173-4120 mL in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/01/2014
Labeler - NuCare Pharmaceuticals,Inc. (010632300)
Establishment
NameAddressID/FEIBusiness Operations
NuCare Pharmaceuticals,Inc.010632300relabel(68071-5173)

Revised: 2/2021
Document Id: bbf62556-4323-89dc-e053-2995a90a1251
Set id: 9e691264-d48a-6b48-e053-2995a90a9352
Version: 2
Effective Time: 20210222
 
NuCare Pharmaceuticals,Inc.