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  5. Label Information: Robitussin Severe Multi-symptom Cough Cold Flu Nighttime

FDA Label for Robitussin Severe Multi-symptom Cough Cold Flu Nighttime

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH 20 ML)
    2. PURPOSES
    3. USES
    4. LIVER WARNING
    5. SORE THROAT WARNING
    6. OTC - DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    9. WHEN USING THIS PRODUCT
    10. STOP USE AND ASK A DOCTOR IF
    11. OTC - PREGNANCY OR BREAST FEEDING
    12. OTC - KEEP OUT OF REACH OF CHILDREN
    13. DIRECTIONS
    14. STORAGE AND HANDLING
    15. INACTIVE INGREDIENT
    16. QUESTIONS OR COMMENTS?
    17. OTHER

Robitussin Severe Multi-symptom Cough Cold Flu Nighttime Product Label

The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients (In Each 20 Ml)



Acetaminophen, USP 650 mg

Diphenhydramine HCl, USP 25 mg

Phenylephrine HCl, USP 10 mg


Purposes



Pain reliever/Fever reducer

Antihistamine/Coughsuppressant

Nasal decongestant


Uses



  • •temporarily relieves these symptoms occurring with a cold or flu, hay fever, or other respiratory allergies:
    • •cough due to minor throat and bronchial irritation
    • •nasal congestion
    • •headache
    • •sore throat
    • •minor aches and pains
    • •runny nose
    • •sneezing
    • •itchy, watery eyes
    • •itching of the nose and throat
    • •temporarily reduces fever

Liver Warning



This product contains acetaminophen. Severe liver damage may occur if you take

  • •more than 6 doses in any 24-hour period, which is the maximum daily amount
  • •with other drugs containing acetaminophen
  • •3 or more alcoholic drinks every day while using this product

    • Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

    • •skin reddening
    • •blisters
    • •rash

      • If a skin reaction occurs, stop use and seek medical help right away.


Sore Throat Warning



If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.


Otc - Do Not Use



Do not use

  • •to sedate a child or to make a child sleepy
  • •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.
  • •with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist.
  • •with any other product containing diphenhydramine, even one used on skin

Ask A Doctor Before Use If You Have



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

Ask A Doctor Or Pharmacist Before Use If You Are



  • •taking the blood thinning drug warfarin
  • •taking any other oral nasal decongestant or stimulant
  • •taking any other pain reliever/fever reducer
  • •taking sedatives or tranquilizers

When Using This Product



  • •do not use more than directed
  • •marked drowsiness may occur
  • •avoid alcoholic drinks
  • •alcohol, sedatives, and tranquilizers may increase drowsiness
  • •be careful when driving a motor vehicle or operating machinery
  • •excitability may occur, especially in children

Stop Use And Ask A Doctor If



  • •you get nervous, dizzy, or sleepless
  • •pain, cough, or nasal congestion gets worse or lasts more than 7 days
  • •fever gets worse or lasts more than 3 days
  • •redness or swelling is present
  • •new symptoms occur
  • •cough comes back or occurs with rash or headache that lasts. 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. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.


Directions



  • •do not take more than 6 doses in any 24-hour period
  • •do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
  • •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
    • agedose

    adults and children 12 years and over

    20 ml every 4 hours

    children under 12 years

    do not use


Storage And Handling



Other information

  • •each 20 ml contains: sodium 15 mg
  • •store at 20-25°C (68-77°F)

Inactive Ingredient



Inactive ingredients

anhydrous citric acid, artificial flavor, edetate disodium, FD&C red no. 40, glycerin, menthol, polyethylene glycol, propyl gallate, 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


Other



Distributed by: Pfizer, Madison, NJ 07940 USA


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