Overview
- Label date
- 2023-10-13
Indications and usage
Use(s) temporarily relieves common cold and flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever runny nose and sneezing nasal congestion (Daytime only)
Purpose
Nighttime only Pain reliever/fever reducer Cough suppressant Antihistamine Daytime only Pain reliever/fever reducer Cough suppressant Nasal decongestant
Dosage and administration
Directions Directions (Nighttime only) take only as directed do not exceed 4 doses per 24 hours Adults and children 12 years and over: 2 softgels with water every 4 hours Children 4 to under 12 years: do not use Children under 4 years: ask a doctor Directions (Daytime only) take only as directed do not exceed 4 doses per 24 hours Adults and children 12 years and over: 2 softgels with water every 6 hours Children 4 to under 12 years: do not use Children under 4 years: ask a doctor
Warnings
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, lasts for more than 2 days, occurs with or followed by fever, headache, rash, nausea, or vomiting, see 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 drugs. 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 (Nighttime only) Ask a doctor before use if liver disease 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 an enlarged prostate gland glaucoma (Nighttime only) heart disease thyroid disease diabetes high blood sugar (Daytime only) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers (Nighttime only) When using this product When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drink be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness Stop use and ask a doctor if pain 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. you get nervous, dizzy or sleepless symptoms get worse or last more than 5 days (children) or 7 days (adults) (Daytime only) These could be signs of a serious condition. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children Taking more than directed can cause serious health problems. 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
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 drugs. 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 (Nighttime only)
Ask a doctor before use if
Ask a doctor before use if liver disease 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 an enlarged prostate gland glaucoma (Nighttime only) heart disease thyroid disease diabetes high blood sugar (Daytime only)
Ask a doctor or pharmacist before use if
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers (Nighttime only)
When using this product
this product When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drink be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness
Stop use and ask a doctor if
and ask a doctor if pain 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. you get nervous, dizzy or sleepless symptoms get worse or last more than 5 days (children) or 7 days (adults) (Daytime only) These could be signs of a serious condition.
Pregnancy or breast-feeding
If pregnant or breastfeeding, ask a health professional before use.
Active ingredient (label)
(s) Active Ingredients (in each softgel) Nighttime only Acetaminophen 325mg Dextromethorphan HBr 15mg Doxylamine succinate 6.25mg Active Ingredients (in each softgel) Daytime only Acetaminophen 325mg Dextromethorphan HBr 10mg Phenylephrine HCl 5mg
Inactive ingredients
s Inactive ingredients (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 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
Keep out of reach of children
of children Taking more than directed can cause serious health problems. 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.