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

OTC RxCUI 1086997
Contents

Overview

Label date
2026-08-06

Indications and usage

Uses

  • temporarily relieves common cold or flu symptoms:
  • Nasal congestion (Daytime only)
  • headache
  • minor aches and pains
  • cough due to minor throat and bronchial irritation
  • sore throat
  • fever
  • runny nose & sneezing (Nighttime only)

Purpose

s (Daytime) Pain reliever/Fever reducer Cough suppressant Nasal decongestant

s (Nighttime) Pain reliever/Fever reducer Cough suppressant Antihistamine

Dosage and administration

Directions

  • take only as directed
  • Do not exceed 8 softgels per 24 hrs Age Daytime Nighttime adults and children 12 years of age and over 2 softgels with water every 4 hrs 2 softgels with water every 6 hrs children under 12 years of age Ask doctor Ask doctor children under 4 years Do not use Do not use If taking Daytime and Nighttime Softgels carefully read each label to ensure dosing

Warnings

Liver warning: 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 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. 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
  • Heart disease (Daytime only)
  • High blood pressure (Daytime only)
  • Thyroid disease (Daytime only)
  • Diabetes (Daytime only)
  • Trouble urinating due to enlarged prostate gland
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema (Nighttime only)
  • cough that occurs with too much phlegm (mucus)
  • glaucoma (Nighttime only)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema (Daytime only) Ask a doctor or pharmacist before use if you are
  • taking sedatives or tranquilizers (Nighttime Only)
  • taking the blood thinning drug warfarin When using this product
  • do not use more than directed
  • excitability may occur, especially in children (Nighttime only)
  • marked drowsiness may occur (Nighttime only)
  • avoid alcoholic drinks (Nighttime only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
  • be careful when driving a motor vehicle or operating machinery (Nighttime only) Stop use and ask a doctor if
  • you get nervous, dizzy or sleepless (Daytime Only)
  • pain or cough gets worse or lasts more than 7 days (Nighttime Only)
  • pain, nasal congestion or cough gets worse or lasts more than 7 days (Daytime only)
  • 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. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 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.

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

Ask a doctor before use if you have

  • liver disease
  • Heart disease (Daytime only)
  • High blood pressure (Daytime only)
  • Thyroid disease (Daytime only)
  • Diabetes (Daytime only)
  • Trouble urinating due to enlarged prostate gland
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema (Nighttime only)
  • cough that occurs with too much phlegm (mucus)
  • glaucoma (Nighttime only)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema (Daytime only)

Ask a doctor or pharmacist before use if

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers (Nighttime Only)
  • taking the blood thinning drug warfarin

When using this product

this product

  • do not use more than directed
  • excitability may occur, especially in children (Nighttime only)
  • marked drowsiness may occur (Nighttime only)
  • avoid alcoholic drinks (Nighttime only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
  • be careful when driving a motor vehicle or operating machinery (Nighttime only)

Stop use and ask a doctor if

and ask a doctor if

  • you get nervous, dizzy or sleepless (Daytime Only)
  • pain or cough gets worse or lasts more than 7 days (Nighttime Only)
  • pain, nasal congestion or cough gets worse or lasts more than 7 days (Daytime only)
  • 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

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

Active ingredient (label)

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

s for Nighttime (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg

Inactive ingredients

s Daytime : -FD&C Red No 40, FD&C Yellow No 6, gelatin, glycerin, polyethylene glycol 400, polyvinyl pyrrolidone, propylene glycol, sorbitol sorbitan anhydrous, titanium dioxide Nighttime : - FD&C Blue No 1, FD&C Yellow No 10, gelatin, glycerin, polyethylene glycol 400, polyvinyl pyrrolidone, propylene glycol, sorbitol sorbitan anhydrous, titanium dioxide

Keep out of reach of children

of children. In case of overdose, get medical help or contact a Poison Control Center right away at 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.