FDA Label for Cvs 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 - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PRINCIPAL DISPLAY PANEL
Cvs Severe Multi-symptom Cough Cold Flu Product Label
The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy. 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
Dextromethorphan HBr, USP 20 mg
Guaifenesin, USP 400 mg
Phenylephrine HCl, USP 10 mg
Purposes
Pain reliever/Fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Indications & Usage
Uses
▪ temporarily relieves these symptoms occurring with a cold or flu:▪ cough due to minor throat and bronchial irritation▪ nasal congestion▪ sinus congestion and pressure▪ 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.
Distributed by:
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▪ heart disease▪ high blood pressure▪ thyroid disease▪ diabetes▪ trouble urinating due to an enlarged prostate gland▪ 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 oral nasal decongestant or stimulant▪ taking any other pain reliever/fever reducer
Otc - When Using
When using this product do not use more than directed
Otc - Stop Use
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 at 1-800-222-1222. 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 7 mg• store at room temperature. Do not refrigerate.
Inactive Ingredient
Inactive ingredients
anhydrous citric acid, edetate disodium, FD&C red no. 40, glycerin, flavors, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum
Otc - Questions
Questions or comments?
1-866-467-2748
Principal Display Panel
Compare to the active ingredients in Adult Robitussin Maximum Strength SEVERE Multi-Symptom Cough Cold + Flu CF MAX*
NDC 51316-630-04
MAXIMUM STRENGTH
Adult
SEVERE
Multi-Symptom
Cough Cold + Flu
ACETAMINOPHEN (Pain Reliever/Fever Reducer)
Dextromethorphan HBr (Cough Suppressant)
Guaifenesin (Expectorant)
Phenylephrine HCl (Nasal Decongestant)
• Cough, Sore Throat• Body Aches, Fever• Nasal Congestion• Chest Congestion
Sugar-Free
No Added Alcohol
Natural Raspberry Flavor
For Ages 12 & Over
8 FL OZ (237 ml)
*This product is not manufactured or distributed by GSK Consumer Healthcare, Owner o the registered trademark Adult Robitussin Maximum Strength SEVERE Multi-Symptom Cough Cold + Flu CF MAX.
* Please review the disclaimer below.