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Drug Facts


OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: (in each 5 mL tsp.)              Purpose

Guaifenesin 50 mg .............................................. ExpectorantDextromethorphan Hydrobromide 5 mg.................. Cough SuppressantPseudoephedrine HCl 15 mg.................................. Nasal Decongestant


OTC - PURPOSE SECTION

  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily relieves these symptoms occurring with a cold: nasal congestion, cough due to minor throat and bronchial irritation.

WARNINGS SECTION

WarningsDo not use in a child who is taking a prescriptionMonoamine Oxidase Inhibitor (MAOI) (certain drugs for depression,psychiatric, or emotional conditions or Parkinson’s disease), or for2 weeks after stopping the MAOI drug. If you do not know if you aretaking a prescription drug that contains a MAOI; ask a doctor orpharmacist before taking this product.


OTC - DO NOT USE SECTION

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to the enlargement of the prostate gland
  • a cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis, or emphysema. A persistent cough may be a sign of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.


OTC - PREGNANCY OR BREAST FEEDING SECTION

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


DOSAGE & ADMINISTRATION SECTION

Directions Do not exceed more than 4 doses in any 24-hour period or as directed by a doctor.

Children 6 to under 12 years of age; 45 lbs to under 95 lbs; Take 2 teaspoonfuls (10mL) every 4 to 6 hours

Children 2 to under 6 years of age; 25 lbs to under 45 lbs; Take 1 teaspoonful (5mL) every 4 to 6 hours

Children under 2 years of age; Under 25 lbs; Ask a doctor


INDICATIONS & USAGE SECTION

  • store at controlled room temperature 20°- 25°C (68° - 77°F); excursion permitted to 15°- 30°C (59°- 86°F) [See USP Controlled Room Temperature]. Tamper evident by imprinted heat seal under cap. Do not use if there is evidence of tampering.

INACTIVE INGREDIENT SECTION

Inactive ingredients aspartame, citric acid, corn syrup, D and C Red No 33, methylparaben, natural and artificial flavors, potassium citrate, potassium sorbate, propylparaben, propylene glycol, purified water.


OTC - QUESTIONS SECTION

Questions or comments? 1-305-403-3788

Manufactured For: Advanced Generic Corporation, Miami, Fl 33166

www.advancedgeneric.com


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL