Drug Facts
Daytime Ultra Concentrated Cold & Flu
Nighttime Ultra Concentrated Cold & Flu
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Health Corp for the product Daytime Nighttime (NDC 51316-875). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredient (in each softgel), purpose, uses, liver warning:, allergy alert:, sore throat warning:, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Daytime Ultra Concentrated Cold & Flu
Nighttime Ultra Concentrated Cold & Flu
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Pain reliever/fever reducer
Cough suppressant
Antihistamine
temporarily relieves common cold/flu symptoms:
• nasal congestion
• cough due to minor throat & bronchial irritation
• sore throat
• headache
• minor aches & pains
• fever
temporarily relieves common cold/flu symptoms:
• cough due to minor throat & bronchial irritation
• sore throat
• headache
• minor aches & pains
• fever
• runny nose & sneezing
This product contains acetaminophen. Severe liver damage may occur if you take
• more than 8 softgels 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
• more than 8 softgels 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
Acetaminophen may cause severe skin reactions. Symptoms may include:
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
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.
• 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.
• liver disease
• glaucoma
• 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
• trouble urinating due to enlarged prostate gland
taking the blood thinning drug warfarin
These could be signs of a serious condition.
• 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.
ask a health professional before use.
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away (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.
• take only as directed
• do not exceed 8 softgels per 24 hrs
| adults & children 12 yrs & over | 2 softgels with water every 4 hrs |
| children 4 to under 12 yrs | ask a doctor |
| children under 4 yrs | do not use |
• take only as directed
• do not exceed 8 softgels per 24 hrs
| adults & children 12 yrs & over | 2 softgels with water every 4 hrs |
| children 4 to under 12 yrs | ask a doctor |
| children under 4 yrs | do not use |
store at no greater than 25°C
store at no greater than 25°C
FD&C yellow no. 6 Al. lake, gelatin, glycerin, mica, polyethylene glycol 400, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide
D&C yellow no. 10 Al. lake, FD&C blue no. 1 Al. lake, gelatin, glycerin, mica, polyethylene glycol 400, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide
Call 1-877-290-4008
Call 1-877-290-4008
• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin
• 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, and tranquilizers may increase drowsiness
In case of overdose, get medical help or contact a Poison Control Center right away (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.
778T carton
778T Daytime label
778T Nighttime label
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