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Pfizer, Madison, NJ 07940 USA
Robitussin Peak Cold Multi-symptom Cold Liquid
FDA Label NDC 0031-8742
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Robitussin Peak Cold Multi-symptom Cold (NDC 0031-8742). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, otc - do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, otc - when using, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients (in each 10 ml) | Purposes |
|---|---|
| Dextromethorphan HBr, USP 20 mg | Cough suppressant |
| Guaifenesin, USP 200 mg | Expectorant |
| Phenylephrine HCl, USP 10 mg | 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
Otc - Do Not Use
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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant.
Otc - When Using
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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
- measure only with dosing cup provided
- keep dosing cup with product
- ml = milliliter
- this adult product is not intended for use in children under 12 years of age
| age | dose |
|---|---|
| adults and children 12 years and over | 10 ml every 4 hours |
| children under 12 years | do not use |
Other Information
- each 10 ml contains: sodium 6 mg
- store at 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredients
anhydrous citric acid, FD&C red no. 40, glycerin, menthol, natural & artificial flavor, 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
For most recent product information,
visit www.robitussin.com
Principal Display Panel - 118 Ml Bottle Carton
ADULT
Robitussin®
PEAK COLD
Multi-Symptom
Cold
DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)
PHENYLEPHRINE HCl (Nasal Decongestant)
Relieves:
✓ Cough✓ Nasal Congestion✓ Mucus
Non-Drowsy CF
For Ages 12 & Over
4 FL OZ
(118 ml)
* Please review the disclaimer below.
