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Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl,Guaifenesin

OTC Oral RxCUI 1297288
Contents

Overview

Route
Oral
Label date
2025-08-18

Indications and usage

Uses DAYTIME temporarily relieves nasal congestion headache cough sinus congestion and pressure minor aches and pains temporarily 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 NIGHTTIME temporarily relieves nasal congestion cough headache sinus congestion and pressure minor aches and pains runny nose and sneezing temporarily promotes nasal and/or sinus drainage

Purpose

for Daytime Pain reliever Cough suppressant Expectorant Nasal decongestant

for Nighttime Pain reliever Cough suppressant Antihistamine Nasal decongestant

Dosage and administration

Directions DAYTIME do not take more than directed (see Overdose warning) do not take more than 12 softgels in any 24-hour period adults and children 12 years of age and older: take 2 softgels every 4 hours children under 12 years of age: do not use when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing NIGHTTIME do not take more than directed (see Overdose warning) do not take more than 12 softgels in any 24-hour period adults and children 12 years of age and older: take 2 softgels every 4 hours children under 12 years of age: do not use when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

Warnings

DAYTIME and NIGHTTIME Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take: more than 4,000 mg of acetaminophen in 24 hours 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 Do not use DAYTIME and NIGHTTIME 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 DAYTIME liver disease high blood pressure diabetes heart disease thyroid disease trouble urinating due to an enlarged prostate gland a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) NIGHTTIME liver disease high blood pressure diabetes heart disease thyroid disease glaucoma trouble urinating due to an enlarged prostate gland breathing problem s such as emphysema or chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are DAYTIME taking the blood thinning drug warfarin NIGHTTIME taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product, DAYTIME do not use more than directed NIGHTTIME do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if DAYTIME and NIGHTTIME nervousness, dizziness, or sleeplessness occur 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 coukld be signs of a serious condition. If pregnant or breast-feeding, DAYTIME and NIGHTTIME ask a health professional before use. Keep out of reach of children. DAYTIME and NIGHTTIME Overdose warning : Taking more than the recommended dose can cause liver damage. 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

DAYTIME and NIGHTTIME 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

Ask a doctor before use if you have DAYTIME liver disease high blood pressure diabetes heart disease thyroid disease trouble urinating due to an enlarged prostate gland a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) NIGHTTIME liver disease high blood pressure diabetes heart disease thyroid disease glaucoma trouble urinating due to an enlarged prostate gland breathing problem s such as emphysema or chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if

Ask a doctor or pharmacist before use if you are DAYTIME taking the blood thinning drug warfarin NIGHTTIME taking the blood thinning drug warfarin taking sedatives or tranquilizers

When using this product

this product, DAYTIME do not use more than directed NIGHTTIME do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

and ask a doctor if DAYTIME and NIGHTTIME nervousness, dizziness, or sleeplessness occur 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 coukld be signs of a serious condition.

Pregnancy or breast-feeding

If pregnant or breast-feeding, DAYTIME and NIGHTTIME ask a health professional before use.

Active ingredient (label)

s in Daytime (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

s in Nighttime (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCI 5 mg

Inactive ingredients

s DAYTIME FD&C red #40, FD&C yellow #6, gelatin, glycerin, mannitiol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide NIGHTTIME D&C yellow #10, FD&C blue #1, gelatin, glycerin, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

Storage and handling

Other information DAYTIME and NIGHTTIME swallow whole; do not crush, chew, or dissolve store between 15-30ºC (59-86F ) avoid excessive heat

Keep out of reach of children

of children. DAYTIME and NIGHTTIME Overdose warning : Taking more than the recommended dose can cause liver damage. 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.