Daytime Nighttime Cold and Flu Relief Combo Pack
Daytime Nighttime Cold and Flu · Kit
Active ingredient
Active ingredient(s) DAYTIME ONLY Acetaminophen 325mg Dextromethorphan HBr 10mg Phenylephrine HCl 5mg NIGHTTIME ONLY Acetaminophen 325mg Dextromethorphan HBr 15mg Doxylamine succinate 6.25mg
Purpose
Purpose DAYTIME ONLY Pain reliever/fever reducer Cough suppressant Nasal decongestant NIGHTTIME ONLY Pain reliever/fever reducer Cough suppressant Antihistamine
Uses
Use(s) DAYTIME ONLY temporarily relieves common cold/flu symptoms:
• nasal congestion
• cough due to minor throat & bronchial irritation
• sore throat
• headache
• minor aches & pains
• fever NIGHTTIME ONLY temporarily relieves common cold/flu symptoms:
• cough due to minor throat & bronchial irritation
• sore throat
• headache
• minor aches & pains
• fever
• runny nose & sneezing
Warnings
Warnings DAYTIME AND NIGHTTIME Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
• more than 4 doses in 24 hrs, 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, occurs with or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use DAYTIME ONLY
• 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. NIGHTTIME ONLY
• 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 Ask a doctor before use if you have DAYTIME ONLY
• liver disease
• heart disease
• thyroid disease
• diabetes
• high blood pressure
• trouble urinating due to an enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough as occurs with smoking, asthma, or emphysema NIGHTTIME ONLY
• 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 or pharmacist before use if DAYTIME ONLY taking the blood thinning drug warfarin. NIGHTTIME ONLY
• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin When using this product DAYTIME ONLY do not use more than directed NIGHTTIME ONLY
• 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 Stop use and ask a doctor if DAYTIME ONLY
• you get nervous, dizzy or sleepless
• symptoms get worse or last more than 5 days (children) or 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. NIGHTTIME ONLY
• 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. Pregnancy/Breastfeeding 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.
Do not use
Do not use DAYTIME ONLY
• 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. NIGHTTIME ONLY
• 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
Ask a doctor before use
Ask a doctor before use if you have DAYTIME ONLY
• liver disease
• heart disease
• thyroid disease
• diabetes
• high blood pressure
• trouble urinating due to an enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough as occurs with smoking, asthma, or emphysema NIGHTTIME ONLY
• 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 or pharmacist
Ask a doctor or pharmacist before use if DAYTIME ONLY taking the blood thinning drug warfarin. NIGHTTIME ONLY
• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin
When using this product
When using this product DAYTIME ONLY do not use more than directed NIGHTTIME ONLY
• 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
Stop use and ask a doctor
Stop use and ask a doctor if DAYTIME ONLY
• you get nervous, dizzy or sleepless
• symptoms get worse or last more than 5 days (children) or 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. NIGHTTIME ONLY
• 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.
Pregnancy or breast-feeding
Pregnancy/Breastfeeding ask a health professional before use.
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 (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.
Directions
Directions DAYTIME ONLY Take only as directed Do not exceed 4 doses in 24 hrs adults and 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 NIGHTTIME ONLY Take only as directed Do not exceed 4 doses in 24 hrs adults and children 12 yrs & over: 2 softgels with water every 6 hrs children 4 to under 12 yrs: ask a doctor children under 4 yrs: do not use
Inactive ingredients
Inactive ingredients DAYTIME ONLY FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, white edible ink NIGHTTIME ONLY D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, white edible ink
Questions?
Questions Questions or comments? Call 1-888-952-0050 Monday through Friday 9AM - 5PM
Label text from the FDA structured product label by Allegiant Health (revised May 19, 2022). Long sections are shortened; the complete label is on DailyMed.
Daytime Nighttime Cold and Flu Relief Combo Pack NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 69168-438 | Kit | Allegiant Health | OTC MONOGRAPH DRUG |
Frequently asked questions
What is Daytime Nighttime Cold and Flu Relief Combo Pack used for?
Use(s) DAYTIME ONLY temporarily relieves common cold/flu symptoms: • nasal congestion • cough due to minor throat & bronchial irritation • sore throat • headache • minor aches & pains • fever NIGHTTIME ONLY temporarily relieves common cold/flu symptoms: • cough due to minor throat & bronchial irritation • sore throat • headache • minor aches & pains • fever • runny nose & sneezing
Who makes Daytime Nighttime Cold and Flu Relief Combo Pack?
Daytime Nighttime Cold and Flu Relief Combo Pack is listed by 1 labeler in the FDA NDC directory, including Allegiant Health.