Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID be51f707-ec9d-47dc-a2fc-9cdc83600b6a
Route
ORAL
Published
Effective Date 2012-07-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Dextromethorphan (30 mg) Doxylamine (12.5 mg)
Inactive Ingredients
Alcohol Citric Acid Monohydrate Fd&c Blue No. 1 Fd&c Yellow No. 5 High Fructose Corn Syrup Polyethylene Glycols Propylene Glycol Water Saccharin Sodium Dihydrate Sodium Citrate Sucrose Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-07-30
Description

Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine

Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Description

Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg

Uses
temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever

  • runny nose and sneezing

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 daily while using this product
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, see a doctor promptly.

Directions
  • take only as directed - see Overdose warning
  • use dose cup or tablespoon (TBSP)

  • do not exceed 4 doses per 24 hours


adults and children 12 yrs and over

 30 ml (2 Tbsp) every 6 hours
children 4 to under 12 yrs

 ask a doctor
children under 4 yrs

 do not use
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.
  • to make a child sleep

Package Label

Nighttime Cold and Flu

Other Information
  • each 30 mL dose cup contains: sodium 43 mg
  • store at room temperature

Overdose Warning:
Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Inactive Ingredients

alcohol, citric acid, FD and C blue no.1, FD and C yellow no.5, flavor, high fructose corn syrup, polyethylene glycol 400, polysorbate 80, propylene glycol, purified water, saccharin sodium, sodium citrate, sucrose, sucralose, xanthan gum

When Using This Product
  • 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, and tranquilizers may increase drowsiness

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.

If Pregnant Or Breast Feeding,
ask a health professional before use.

Keep Out of Reach of Children.




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
  • a sodium-restricted diet

Active Ingredients (in Each 30ml Dose Cup)



Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking sedatives or tranquilizers.
  • taking the blood thinning drug warfarin

Structured Label Content

Uses
temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever

  • runny nose and sneezing

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

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 daily while using this product
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, see a doctor promptly.

Directions
  • take only as directed - see Overdose warning
  • use dose cup or tablespoon (TBSP)

  • do not exceed 4 doses per 24 hours


adults and children 12 yrs and over

 30 ml (2 Tbsp) every 6 hours
children 4 to under 12 yrs

 ask a doctor
children under 4 yrs

 do not use
Do Not Use (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.
  • to make a child sleep

Package Label

Nighttime Cold and Flu

Other Information (Other information)
  • each 30 mL dose cup contains: sodium 43 mg
  • store at room temperature

Overdose Warning: (Overdose warning:)
Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Inactive Ingredients (Inactive ingredients)

alcohol, citric acid, FD and C blue no.1, FD and C yellow no.5, flavor, high fructose corn syrup, polyethylene glycol 400, polysorbate 80, propylene glycol, purified water, saccharin sodium, sodium citrate, sucrose, sucralose, xanthan gum

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 drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness

Stop Use and Ask A Doctor If (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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)
ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)




Ask A Doctor Before Use If You Have (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
  • a sodium-restricted diet

Active Ingredients (in Each 30ml Dose Cup) (Active ingredients (in each 30mL dose cup))



Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking sedatives or tranquilizers.
  • taking the blood thinning drug warfarin

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:29.863363 · Updated: 2026-03-14T22:53:14.066899