Childrens Robitussin Cough and Cold CF description, usages, side effects, indications, overdosage, supplying and lots more!

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Childrens Robitussin Cough and Cold CF

Richmond Division of Wyeth

CHILDREN'S ROBITUSSIN COUGH & COLD CF


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients
(in each 5 mL tsp)
Purposes
Dextromethorphan HBr, USP 5 mg Cough suppressant
Guaifenesin, USP 50 mg Expectorant
Phenylephrine HCl, USP 2.5 mg Nasal decongestant

Childrens Robitussin Cough and Cold CF Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • temporarily relieves these symptoms occurring 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

Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant.

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 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
children under 6 years do not use
children 6 to under 12 years 2 teaspoons every 4 hours
adults and children
12 years and over
4 teaspoons every 4 hours

Childrens Robitussin Cough and Cold CF Other information

  • each teaspoon contains: sodium 3 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.
  • dosage cup provided

Inactive ingredients

anhydrous citric acid, artificial flavor, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Questions or comments?

call weekdays from 9 AM to 5 PM EST at 1-800-762-4675

Distributed by:
Pfizer, Madison, NJ 07940 USA

For most recent product information, visit
www.robitussin.com

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

Children's
Robitussin
®
Cough & Cold

DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)
PHENYLEPHRINE HCl (Nasal Decongestant)

CF

NON-DROWSY

RELIEVES:

Cough
Chest Congestion/Mucus
Stuffy Nose

See NEW Dosing
Information

GRAPE Flavor

For Children Ages 6 & Over

4 FL OZ (118 ml)

Childrens Robitussin Cough and Cold CF

Childrens Robitussin Cough and Cold CF

DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0031-8716
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 5 mg
Guaifenesin GUAIFENESIN 50 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 2.5 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS CITRIC ACID
FD&C RED NO. 40
GLYCERIN
PROPYLENE GLYCOL, (R)-
water
SODIUM BENZOATE
SODIUM CITRATE
sorbitol
Sucralose

Product Characteristics

Color
RED (clear red)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 NDC:0031-8716-12 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2009-09-01


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Be sure to consult your doctor before taking any medication!
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