RELCOF-C- codeine phosphate and guaifenesin liquid 
Burel Pharmaceuticals, 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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RELCOF-C

Drug Facts

Active ingredients
(in each teaspoonful (5 mL))		Purpose
Codeine Phosphate 6.3 mgAntitussive
Guaifenesin 100 mgExpectorant

Uses

  • temporarily relieves
  • cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
  • your cough to help you sleep
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes cough more productive.

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.

Directions

  • do not exceed 6 doses in 24 hours.
Adults and children 12 years of age and over3 tsp (15 mL) every 4 - 6 hours
Children 6 to under 12 years of age1 ½ tsp (7.5 mL) every 4 - 6 hours
Children under 6 years of ageConsult a doctor

Other information

Each teaspoonful contains 6 mg of sodium. Store at controlled room temperature 15°-30°C (59°-86°F).

Inactive ingredients

Citric Acid, Cherry Flavor, Glycerin, Polyethylene Glycol, Povidone, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, and Sorbitol.

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 35573-006-16

RELCOF
            C

ANTITUSSIVE
(cough suppressant)
EXPECTORANT

Each 5mL (one teaspoonful) for oral
administration contains:

Codeine Phosphate6.3 mg
Guaifenesin100 mg

TAMPER EVIDENT:
Do not use if imprinted
neck band is broken or missing.

BUREL
PHARMACEUTICALS

Mfg. for: Burel Pharmaceuticals, Inc.
464 Church Road Ste. 100
Madison, MS 39110

16 fl. oz. (473 mL)

Principal Display Panel - 473 mL Bottle Label
RELCOF-C 
codeine phosphate and guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35573-006
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Codeine Phosphate (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) Codeine Phosphate6.3 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)  
Polyethylene Glycol (UNII: 3WJQ0SDW1A)  
Povidone (UNII: FZ989GH94E)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Water (UNII: 059QF0KO0R)  
Sodium Benzoate (UNII: OJ245FE5EU)  
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:35573-006-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product09/02/200912/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34109/02/200912/31/2017
Labeler - Burel Pharmaceuticals, LLC (002152814)
Registrant - Burel Pharmaceuticals, LLC (002152814)
Establishment
NameAddressID/FEIBusiness Operations
TG United, Inc.172837085manufacture(35573-006)

Revised: 10/2018
Document Id: 1b8b57d5-03e2-4020-a09c-57fe72e49285
Set id: 357c9914-8d87-43d0-ba2f-516a0a455175
Version: 2
Effective Time: 20181011
 
Burel Pharmaceuticals, LLC