Cough Formula Cough and Cold description, usages, side effects, indications, overdosage, supplying and lots more!

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Cough Formula Cough and Cold

Rij Pharmaceutical Corporation

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each 5 mLtsp)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg

Phenylephrine HCl, USP 5 mg

Purpose

Cough suppressant

Expectorant

Nasal decongestant

Cough Formula Cough and Cold Uses

helps loosen phlegm (mucus) and thin bronchial secretions to to drain bronchial tubes

temporarily relieves these symptoms occuring with a cold

nasal congestion

cough due to minor throat and bronchial irritation

Warnings

Do not use

  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

When using this product do not use more than directed.

Stop use and ask a doctor if

  • you get nervous, dizzy, or sleepless
  • symptoms do not get better within 7 days or are accompanied by fever
  • cough that lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs 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 take more than 6 doses in any 24-hour period
age dose
adults and children 12 years and over 2 teaspoonfuls every 4 hours
children 6 years to under 12 years 1 teaspoonful every 4 hours
children 2 years to under 6 years 1/2 teaspoonful every 4 hours
children under 2 years ask a doctor

Cough Formula Cough and Cold Other information

  • TAMPER EVIDENT: DO NOT USE IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING
  • •store at room temperature 15º - 30ºC (59º - 86ºF)
  • •alocohol free
  • •not a USP elixir
  • •each teaspoon (5 mL) contains: sodium 2 mg.

Inactive ingredients

citric acid, FD&C red no. 40, , flavors, glycerin, menthol, propylene glycol, sodium benzoate, sodium saccharin, water

PRINCIPAL DISPLAY PANEL

Cough Formula Cough and Cold

Cough Formula Cough and Cold

dextromethorphan hbr, guaifenesin, phenylephrine hcl LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:53807-531
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 10 mg
Guaifenesin GUAIFENESIN 100 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS CITRIC ACID
FD&C RED NO. 40
MENTHOL
saccharin sodium
SODIUM BENZOATE
water
GLYCERIN

Product Characteristics

Color
RED

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53807-531-04 118 in 1 BOTTLE
2 NDC:53807-531-08 236 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 1999-03-16


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Be sure to consult your doctor before taking any medication!
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