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Refenesen

REESE PHARMACEUTICAL CO.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient per teaspoonful (5 mL)

Guaifenesin, 200 mg

Purpose

Expectorant

Refenesen Uses

Helps loosen phlegm (mucus) and thin bronchial secretions to:

  • •rid the bronchial passageways of bothersome mucus
  • •drain bronchial tubes
  • •make coughs more productive

Warnings

Ask a doctor before use if you have

  • •a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • •a cough accompanied by excessive phlegm (mucus)

When using this product

do not exceed recommended dosage.

Stop use and ask a doctor if

cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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

Do not exceed 6 doses in a 24-hour period

Adults and Children 12 years of age and older:

1 - 2 teaspoonfuls (5 - 10 mL) every 4 hours

Children 6 to under 12 years of age:

1/2 - 1 teaspoonful (2.5 - 5 mL) every 4 hours

Children 2 to under 6 years of age:

1/4 – 1/2 teaspoonful (1.25 - 2.5 mL) every 4 hours

Children under 2 years of age:

Consult a doctor

Refenesen Other information

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F).

Inactive Ingredients

citric acid anhydrous, D&C red #3, FD&C blue #1, flavor, glycerin, methylparaben, polyethylene glycol 1450, propylparaben, saccharin sodium, sodium citrate dihydrate, sorbitol 70% solution

Questions?

1-800-321-7178

Package/Label Principal Display Panel

Refenesen

guaifenesin SYRUP

Product Information

Product Type Human otc drug label Item Code (Source) NDC:10956-200
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Guaifenesin GUAIFENESIN 200 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS CITRIC ACID
D&C RED NO. 33
FD&C BLUE NO. 1
GLYCERIN
METHYLPARABEN
POLYETHYLENE GLYCOL 1450
PROPYLPARABEN
saccharin sodium
sorbitol
TRISODIUM CITRATE DIHYDRATE

Product Characteristics

Color
PURPLE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 NDC:10956-200-04 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2014-05-15


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Be sure to consult your doctor before taking any medication!
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