FDA Label for Robitussin Maximum Strength Severe Multi-symptom Cough Cold Flu
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH 20 ML)
- PURPOSES
- INDICATIONS & USAGE
- WARNINGS
- LIVER WARNING:
- OTHER
- SORE THROAT WARNING
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- ADDITIONAL INFORMATION
- PRINCIPAL DISPLAY PANEL
Robitussin Maximum Strength Severe Multi-symptom Cough Cold Flu 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 650 mg
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Purposes
Pain reliever/Fever reducer
Cough suppressant
Expectorant
Indications & Usage
Uses
- temporarily relieves these symptoms occurring with a cold or flu:
- cough due to minor throat and bronchial irritation
- minor aches and pains
- sore throat
- headache
- temporarily reduces fever
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
Warnings
Warnings
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
Other
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
- 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.
Otc - Ask Doctor
Ask a doctor before use if you have
- liver disease
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking any other pain reliever/fever reducer
Otc - Stop Use
Stop use and ask a doctor if
- pain or cough 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.
Dosage & Administration
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
age | dose |
---|---|
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 14 mg
- store at 20-25°C (68-77°F)
Inactive Ingredient
Inactive ingredients
anhydrous citric acid, edetate disodium, FD&C red no. 40, glycerin, menthol, natural and artificial flavors, polyethylene glycol, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, triacetin, xanthan gum
Otc - Questions
Questions or comments?
call weekdays from 8 AM to 6 PM EST at 1-800-245-1040
Additional Information
Maximum Strength claim based on maximum levels of active ingredients per 4 hour dose.
ADULT
Robitussin
MAXIMUM STRENGTH
SEVERE MULTI-SYMPTOM
Cough Cold + Flu CF MAX
Do Not Use if breakable ring on bottle cap is separated or missing.
PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org
Distributed by: Haleon, Warren, NJ 07059
For most recent product information, visit www.robitussin.com
Trademarks owned or licensed by Haleon.
Pat. Info www.productpats.com
©2023 Haleon or licensor. Made in Canada
Principal Display Panel
ADULT NEW FORMULA HALEON
Robitussin
MAXIMUM STRENGTH
SEVERE
MULTI-SYMPTOM
Cough Cold + Flu
ACETAMINOPHEN (Pain Reliever/Fever Reducer)
DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)
✓Cough, Sore Throat
✓Head & Body Aches, Fever
✓Chest Congestion
✓Thins & Loosens Mucus
FAST, POWERFUL
multi-symptom relief
CF
MAX
For Ages 12 & Over
8 FL OZ (237 mL)
62000000207716 Front Carton
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