FDA Label for Severe Cold Plus Flu Daytime Nighttime
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USES
- LIVER WARNING
- ALLERGY ALERT
- SORE THROAT WARNING
- 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
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- PRINCIPAL DISPLAY PANEL-
Severe Cold Plus Flu Daytime Nighttime 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.
Other
Severe Cold + Flu DayTime
Drug Facts
Severe Cold + Flu Nighttime
Drug Facts
Otc - Purpose
| Active ingredients (in each packet) | Purposes |
|---|---|
Acetaminophen 500 mg | Pain reliever/fever reducer |
Dextromethorphan hydrobromide 20 mg | Cough suppressant |
Guaifenesin 400 mg | Expectorant |
Phenylephrine hydrochloride 10 mg | Nasal decongestant |
| Active ingredients (in each packet) | Purposes |
|---|---|
Acetaminophen 650 mg | Pain reliever/fever reducer |
Dextromethorphan hydrobromide 20 mg | Cough suppressant |
Doxylamine succinate 12.5 mg | Antihistamine |
Phenylephrine hydrochloride 10 mg | Nasal decongestant |
Uses
• temporarily relieves these symptoms due to a cold or flu:• minor aches and pains• headache• sore throat• cough• nasal congestion• sinus congestion and pressure
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus• temporarily reduces fever• temporarily relieves these symptoms due to a cold or flu:• headache• minor aches and pains• cough• sore throat• nasal congestion• sinus congestion and pressure• runny nose• sneezing
• temporarily reduces fever
Liver Warning
This product contains acetaminophen. Severe liver damage may occur if you take
• more than 6 packets in 24 hours, which is the maximum daily amount for this product• with other drugs containing acetaminophen• 3 or more alcoholic drinks every day while using this product• more than 5 packets in 24 hours, which is the maximum daily amount for this product• with other drugs containing acetaminophen• 3 or more alcoholic drinks every day while using this product
This product contains acetaminophen. Severe liver damage may occur if you take
Allergy Alert
Is a skin or general allergic 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.
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 to sedate children.
Do Not Use
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or 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 an MAOI, ask a doctor or pharmacist before taking this product.• if you have ever had an allergic reaction to this product or any of its ingredients• in children under 12 years of age• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or 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 an MAOI, ask a doctor or pharmacist before taking this product.• if you have ever had an allergic reaction to this product or any of its ingredients• in children under 12 years of age
Ask A Doctor Before Use If You Have
• liver disease• heart disease• high blood pressure• thyroid disease• diabetes• difficulty in urination due to enlargement of the prostate gland• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema• cough with excessive phlegm (mucus)• liver disease• heart disease• high blood pressure• thyroid disease• diabetes• glaucoma• cough with excessive phlegm (mucus)• a breathing problem such as emphysema or chronic bronchitis• difficulty in urination due to enlargement of the prostate gland• persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Otc - When Using
When using this product do not exceed recommended dosage
Stop Use And Ask A Doctor If
• 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.• nervousness, dizziness, or sleeplessness occurs• 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.• nervousness, dizziness, or sleeplessness occurs
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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. Quick 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 the recommended dose• take every 4 hours; do not exceed 6 packets in 24 hours or as directed by a doctor• adults and children 12 years and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.• children under 12 years: do not use• do not take more than the recommended dose• take every 4 hours; do not exceed 5 packets in 24 hours or as directed by a doctor• adults and children 12 years and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.• children under 12 years: do not use
Other Information
• each packet contains: potassium 6 mg• store at room temperature• each packet contains: potassium 6 mg• store at room temperature
Inactive Ingredients
anhydrous citric acid, flavors, maltodextrin, potassium citrate, silica, sucralose,sucrose,yellow#6
anhydrous citric acid, flavors, maltodextrin, potassium citrate, silica, sucralose,sucrose,yellow#6
Questions Or Comments?
1-866-467-2748
1-866-467-2748
Ask A Doctor Or Pharmacist Before Use If You Are
• taking the blood thinning drug warfarin• taking sedatives or tranquilizers
When Using This Product
• do not exceed recommended dosage• may cause marked drowsiness• 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
Principal Display Panel-
Compare to Alka-Seltzer PLUS® Severe Cold +Flu Day and Night Active Ingredients*
SEVERE COLD + FLU
DAYTIME
Acetaminophen / Pain reliever-fever reducer
Dextromethorphan HBr / Cough suppressant
Guaifenesin / Expectorant
Phenylephrine HCl / Nasal decongestant
Fast Relief
• Nasal Congestion • Headache
• Sore Throat • Body Ache • Cough
• Mucus • Chest Congestion • Fever
Aspirin Free
Aspartame Free
Honey Lemon Flavor
Naturally and Artificially Flavored
NIGHTTIME
Acetaminophen / Pain reliever-fever reducer
Dextromethorphan HBr / Cough suppressant
Doxylamine succinate / Antihistamine
Phenylephrine HCl / Nasal decongestant
Fast Relief
• Nasal Congestion • Headache
• Sore Throat • Body Ache
• Cough • Runny Nose • Fever
Aspirin Free
Aspartame Free
Honey Lemon Flavor
Naturally and Artificially Flavored
Tamper Evident Inner Unit: Do not use if sealed Packet is Torn or Broken |
DO NOT TAKE THESE PRODUCTS AT THE SAME TIME
6 DAY PACKETS + 6 NIGHT PACKETS
12 TOTAL
*These products is not manufactured or distributed by Bayer Healthcare, LLC, distributor of Alka-Seltzer plus® Severe Cold +Flu Day and Night.
* Please review the disclaimer below.