The following Structured Product Label (SPL) was submitted to the FDA by Grocery Outlet, Inc. for the product Daytime And Nighttime (NDC 85828-773). 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 other, active ingredients (in each 30 ml), purpose, uses, warnings, liver warning:, allergy alert:, sore throat warning:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Nighttime Cold & Flu
Drug Facts
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg
Pain reliever/ fever reducer
Cough suppressant
Antihistamine
Pain reliever/Fever reducer
Cough suppressant
Nasal decongestant
temporarily relieves common cold/flu symptoms:
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.
■ with other drugs containing acetaminophen
■ 3 or more alcoholic drinks every day while using this product
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.
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.
Liver warning:This product contains acetaminophen. Severe liver
damage may occur if
■ adult takes more than 4 doses (30 mL each) in 24 hrs, which is the maximum daily amount for this product
■ child takes more than 4 doses (15 mL each) in 24 hrs, which is the maximum daily amount for this product
■ taken with other drugs containing acetaminophen
■ adult has 3 or more alcoholic drinks every day while using this product
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.
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.
This product contains acetaminophen. Severe liver damage may occur if you take
This product contains acetaminophen. Severe liver damage may occur if
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.
taking the blood thinning drug warfarin.
These could be signs of a serious condition.
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 (1-800-222-1222) 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.
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.
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.
Ask a doctor before use if you have
■ 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
Ask a doctor before use if you have
■ liver disease
■ heart disease
■ high blood pressure
■ thyroid disease
■ diabetes
■ trouble urinating due to enlarged prostate gland
■ cough that occurs with too much phlegm (mucus)
■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema
■ a sodium-restricted diet
Ask a doctor or pharmacist before use if you are
■ taking sedatives or tranquilizers
■ taking the blood thinning drug warfarin
Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin.
When using this product
■ 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
When using this product, do not use more than directed.
Stop use and ask a doctor if
■ 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.
Stop use and ask a doctor if
■ you get nervous, dizzy or sleepless
■ pain, nasal congestion or cough get worse or last more than 5 days (children) and 7 days (adults)
■ 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.
If pregnant or breast-feeding,ask a health professional before use.
If pregnant or breast-feeding,ask a health professional before use.
Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
| adults & children 12 yrs & over | 30 mL every 6 hrs |
| 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 hrs |
| children 6 to under 12 yrs | 15 mL every 4 hrs |
| children 4 to under 6 yrs | ask a doctor |
| children under 4 yrs | do not use |
alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution, sucralose, xanthan gum
anhydrous citric acid, FD&C yellow no. 6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate, sodium saccharin, sorbitol solution, sucralose, xanthan gum
Call 1-877-290-4008
Call 1-877-290-4008
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCI 5 mg
do not use more than directed.
Shrink-label (Shrink Label)
* Please review the disclaimer below.
