ROBITUSSIN PEAK COLD MAXIMUM STRENGTH MULTI-SYMPTOM COLD description, usages, side effects, indications, overdosage, supplying and lots more!

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ROBITUSSIN PEAK COLD MAXIMUM STRENGTH MULTI-SYMPTOM COLD

Richmond Division of Wyeth

Robitussin Peak Cold Maximum Strength Multi-Symptom Cold(dextromethorphan HBr, guaifenesin, and phenylephrine HCl)


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DRUG FACTS

ACTIVE INGREDIENTS (IN EACH 5 ML TSP)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 200 mg

Phenylephrine HCl, USP 5 mg

PURPOSES

Cough suppressant

Expectorant

Nasal decongestant

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

  • shake well before using
  • do not take more than 6 doses in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age
age dose
adults and children 12 years and over 2 teaspoons every 4 hours
children under 12 years do not use

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, FD&C red no. 40, glycerin, menthol, natural flavor, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose , xanthan gum

QUESTIONS OR COMMENTS?

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

PRODUCT PACKAGING

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

Formerly CF Max

ADULT

Robitussin PEAK COLD MAXIMUM STRENGTH Multi-Symptom Cold

DEXTROMETHORPHAN HBr (Cough Suppressant)

GUAIFENESIN (Expectorant)

PHENYLEPHRINE HCl (Nasal Decongestant)

Relieves:

  • Nasal Congestion
  • Cough
  • Mucus

Non-Drowsy

For Ages 12 & Over

8 FL OZ (237 ml)

Find the right product for you with the Robitussin Relief Finder on Robitussin.com

  • at home
  • on your mobile phone

Use dosage cup included

Pfizer, Madison, NJ 07940 USA

© 2011 Pfizer Inc.

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

Droplet is not representative of actual product color.

Should be 18 or older to purchase

PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org

Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing.

Maximum strength claim based on maximum daily dose of active ingredients.

ROBITUSSIN PEAK COLD MAXIMUM STRENGTH MULTI-SYMPTOM COLD

ROBITUSSIN PEAK COLD MAXIMUM STRENGTH MULTI-SYMPTOM COLD

dextromethorphan HBr, guaifenesin, phenylephrine HCl LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0031-8734
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 10 mg
Guaifenesin GUAIFENESIN 200 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS CITRIC ACID
FD&C RED NO. 40
GLYCERIN
MENTHOL
polyethylene glycol
propylene glycol
SODIUM BENZOATE
SODIUM CITRATE
sorbitol
Sucralose
XANTHAN GUM
water

Product Characteristics

Color
RED (translucent red)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 237 in 1 BOTTLE
3 NDC:0031-8734-18 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2011-06-15


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Be sure to consult your doctor before taking any medication!
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