RelCof-C description, usages, side effects, indications, overdosage, supplying and lots more!

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RelCof-C

Burel Pharmaceuticals, LLC

RELCOF-C


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients
(in each teaspoonful (5 mL))
Purpose
Codeine Phosphate 6.3 mg Antitussive
Guaifenesin 100 mg Expectorant

RelCof-C 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 over 3 tsp (15 mL) every 4 - 6 hours
Children 6 to under 12 years of age 1 ½ tsp (7.5 mL) every 4 - 6 hours
Children under 6 years of age Consult a doctor

RelCof-C 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 Phosphate 6.3 mg
Guaifenesin 100 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)

RelCof-C

RelCof-C

Codeine Phosphate and Guaifenesin LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:35573-006
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CODEINE PHOSPHATE CODEINE ANHYDROUS 6.3 mg
Guaifenesin GUAIFENESIN 100 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
GLYCERIN
polyethylene glycol
povidone
propylene glycol
water
SODIUM BENZOATE
SODIUM CITRATE
saccharin sodium
sorbitol

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:35573-006-16 473 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2009-09-02


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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