FDA Label for Cvs Daytime And Nighttime Value Pack Cold And Flu
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENTS (IN EACH 30 ML)
- PURPOSE
- USES
- LIVER WARNING
- ALLERGY ALERT:
- SORE THROAT WARNING:
- DO NOT USE
- 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?
- ACTIVE INGREDIENTS (IN EACH CAPLET)
- WHEN USING THIS PRODUCT
- PRINCIPAL DISPLAY PANEL - KIT CARTON
Cvs Daytime And Nighttime Value Pack Cold And 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.
Other
DayTime Cold & Flu
NIGHTTIME COLD & FLU RELIEF
Distributed By:
Active Ingredients (In Each 30 Ml)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 mg
Purpose
Pain reliever/Fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Pain reliever/Fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
Uses
• temporarily relieves common cold/flu symptoms:• nasal congestion• sinus congestion & pressure• cough due to minor throat & bronchial irritation• minor aches & pains• headache• fever• sore throat• reduces swelling of nasal passages• temporarily restores freer breathing through the nose• promotes nasal and/or sinus drainage• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive• nasal congestion• sinus congestion & pressure• cough due to minor throat & bronchial irritation• cough to help you sleep• minor aches & pains• headache• fever• sore throat• runny nose & sneezing •reduces swelling of nasal passages• temporarily restores freer breathing through the nose• promotes nasal and/or sinus drainage
temporarily relieves common cold/flu symptoms:
Liver Warning
This product contains acetaminophen.
Severe liver damage may occur if you take
• more than 4 doses in 24 hours, which is the maximum daily amount for this product• taken with other drugs containing acetaminophen• 3 or more alcoholic drinks every day while using this product• more than 4 doses in 24 hours, which is the maximum daily amount for this product• taken 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:
Acetaminophen may cause severe skin reactions. Symptoms may include:
• Skin reddening• Blisters• Rash• Skin reddening• Blisters• Rash
If a skin reaction occurs, stop use and seek medical help right away
acetaminophen may cause severe skin reactions.
Symptoms may include:
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.
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
• 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.• 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.• to make a child sleep
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 use more than directed.
Stop Use And Ask A Doctor If
• you get nervous, dizzy or sleepless• pain, nasal congestion, 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.• you get nervous, dizzy or sleepless• pain, nasal congestion, 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.
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. 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
• take only as directed• Only use the dose cup provided• do not exceed 4 doses per 24 hrs• take only as directed• Only use the dose cup provided• do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over | 30 mL every 4 hours |
children 4 to under 12 yrs | ask a doctor |
children under 4 yrs | do not use |
adults & children 12 yrs & over | 30 mL every 4 hours |
children 4 to under 12 yrs | ask a doctor |
children under 4 yrs | do not use |
Other Information
each 30 mL contains:
• sodium 81 mg• store at room temperature• Do not refrigerate.• each 30 mL contains: sodium 81 mg• Store at room temperature• Do not refrigerate
Inactive Ingredients
Citric acid, D&C Yellow No. 10, disodium edetate, FD&C Blue No.1, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose
Citric acid, D&C Yellow No. 10, disodium edetate, FD&C Blue No.1, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose
Questions?
1-866-467-2748
1-866-467-2748
Active Ingredients (In Each Caplet)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Doxylamine succinate 12.5 mg
Phenylephrine HCl 10 mg
When Using This Product
• do not use more than directed• excitability may occur, especially in children• marked drowsiness may occur• avoid alcoholic drinks• be careful when driving a motor vehicle or operating machinery• alcohol, sedatives & tranquilizers may increase drowsiness
Principal Display Panel - Kit Carton
**Compare to the active ingredients in Vicks®DayQuil™ Severe+ VapoCOOL™
NDC# 51316-156-24
DayTime
Cold & Flu
Relief
Acetaminophen – Pain reliever/Fever reducer
Dextromethorphan HBr – Cough suppressant
Guaifenesin - Expectorant
Phenylephrine HCl – Nasal decongestant
For Relief of
• Minor Aches & Pains, Fever• Nasal Congestion & Sinus Pressure• Cough• Chest Congestion• Minor Aches & Pains, Fever• Nasal Congestion & Sinus Pressure• Sneezing, Runny Nose• Cough
*Compare to the active ingredients in Vicks®NyQuil™ Severe+ VapoCOOL™
NightTime
Cold & Flu
Relief
Acetaminophen – Pain reliever/Fever reducer
Dextromethorphan HBr – Cough suppressant
Phenylephrine HCl - Antihistamine
Phenylephrine HCl – Nasal decongestant
For Relief of
TWO BOTTLES, 12 FL OZ (354 mL) each; TOTAL 24 FL OZ (708 mL)
**This product is not manufactured or distributed by Procter & Gamble, distributor of Vicks®Dayquil™ Severe+ VapoCOOL™ and Vicks® Nyquil™ Severe+ VapoCOOL™
* Please review the disclaimer below.