FDA Label for Cvs Health Multi Symptom Severe Cold Multi Symptom Severe Cold
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH PACKET)
- PURPOSES
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS
- PRINCIPAL DISPLAY
Cvs Health Multi Symptom Severe Cold Multi Symptom Severe Cold Product Label
The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy,inc.. 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 Packet)
Acetaminophen 500 mg
Dextromethorphan hydrobromide 20 mg
Phenylephrine hydrochloride 10 mg
Purposes
Pain reliever / fever reducer
Cough Suppressant
Nasal Decongestant
Uses
• temporarily relieves these symptoms due to a cold:• temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
• more than 4,000 mg of acetaminophen in 24 hours• with other drugs containing acetaminophen• 3 or more alcoholic drinks every day while using this product
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.
Do Not Use
• in a child under 4 years of age• if you are allergic to acetaminophen• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist.• 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 a MAOI, ask a doctor or pharmacist before taking this product.
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)• cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin
When Using This Product
do not exceed recommended dosage
Stop Use And Ask A Doctor If
• nervousness, dizziness, or sleeplessness occurs• fever gets worse or lasts more than 3 days• redness or swelling is present• new symptoms occur• symptoms do not get better or worsen• pain, cough or nasal congestion gets worse or lasts more than 7 days• cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health care professional before use.
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.
Directions
• do not use more than directed• take every 4 hours ; not to exceed 6 packets in 24 hours or as directed by a doctor• dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10 - 15 minutes.• if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating, Do not overheat.
Age | Dose |
children under 4 years of age | do not use |
children 4 to under 12 years of age | do not use unless directed by a doctor |
adults and children 12 years of age and over | one packet |
Other Information
• each packet contains: potassium 6 mg• store at controlled room temperature 20°-25°C (68°-77°F). Protect from excessive heat and moisture.
Inactive Ingredients
anhydrous citric acid, caramel, flavors, maltodextrin ,potassium citrate, silica, sucralose, sucrose,
Questions Or Comments
1-866-467-2748
Principal Display
CVS Health™
Compare to the active ingredients in Theraflu® Multi-Symptom Severe Cold*
Severe
NDC 59779-877-06
Multi-Symptom
Severe Cold
ACETAMINOPHEN
Pain reliever; Fever reducer
DEXTROMETHORPHAN HBr
Cough suppressant
PHENYLEPHRINE HCl
Nasal decongestant
Relieves:
• Nasal congestion• Sore throat pain• Cough• Headache• Body ache• Fever
Green Tea & Honey Lemon Flavors
6 PACKETS
READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE, KEEP CARTON FOR REFERENCE, DO NOT DISCARD,
Multi-Symptom Severe Cold
CVS Health™ Multi-Symptom Severe Cold provides complete relief of your severe cold symptoms. This soothing hot liquid formula is dye free, aspartame free and sodium free and tastes great.
For nighttime relief, try CVS Health™ Nighttime Severe Cough & Cold.
TAMPER EVIDENT INNER UNIT: DO NOT USE IF SEALED PACKET IS TORN OR BROKEN.
Dye, Aspartame, & Sodium free
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
©2015 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
V-12431
CVS® Quality
Money back Guarantee
*This product is not manufactured or distributed by Novartis Consumer Health Inc., distributor of Theraflu® Multi-Symptom Severe Cold
* Please review the disclaimer below.