Xl-3 Night Time

Xl-3 Night Time
SPL v3
SPL
SPL Set ID 03210929-331e-462d-b566-4e1865f52246
Route
ORAL
Published
Effective Date 2026-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Doxylamine (12.5 mg) Acetaminophen (650 mg) Dextromethorphan (30 mg)
Inactive Ingredients
Propylene Glycol Fd&c Red No. 40 Sodium Benzoate Sucralose Xanthan Gum Citric Acid Fd&c Blue No. 1 Sorbitol Solution Menthol Glycerin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-01

Description

Active ingredientes (in each 30mL dose cup) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine Succinate 12.5 mg


Medication Information

Warnings and Precautions

Warnings

Liver warning: This product contains acetaminophen. Sever 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 sever skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is sever, persist for more than two days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly

Indications and Usage

Uses

temporarily relieves cold/flu symptoms:

  • sore throat
  • headache
  • minor aches and pain
  • fever
  • runny nose and sneezing
  • cough due to minor throat and bronchial irritation
Dosage and Administration
  • take only as recommended- see Overdose warning
  • use only dosing cup provided
  • keep dosing cup provided with the product
  • do not exceed 4 doses per 24 hours
  • if taking Day Time during the day and Night Time at night, limit the total to 4 doses per 24 hours
  • TBSP=tablespoon
  • mL=mililiter

adults & children 12 years and over

30 mL (2 TBSP) every 6 hours
children 4 to under 12 years ask a doctor
children under 4 years do not use

Description

Active ingredientes (in each 30mL dose cup) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine Succinate 12.5 mg

Section 34088-5

Overdose warning: Taking more than the recommended dose (overdose) may cause serious health problems including liver damage. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if

  • redness or swelling is present
  • symptoms do not get better within 7 days or are accompanied by a fever
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • cough lasts more than 7 days, comes back, or occurs wih fever, rash or headache that lasts. These could be signs of a serious condition.
Section 50567-7

When using this product

  • do not use more than directed
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives and tranquilizers may increase drowsiness.
Section 50568-5

Ask a doctor or pharmacist before use

  • if you are taking sedatives or tranquilizers
  • if you are taking the blood thinning drug warfarin.
Section 50569-3

Ask a doctor before use if you have

  • a sodium restricted diet
  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs wtih smoking, asthma, chronic bronchitis or emphysema
  • trouble urinating due to enlarged prostate gland
Section 50570-1

Do not use

with any other products containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist

  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's diseas), 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 sleepy
Section 51727-6

Inactive ingredients: Citric acid, FD&C Blue #1, FD&C Red #40, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum.

Section 51945-4

Section 53413-1

Questions or Comments? 1-888-446-4753

Monday - Friday from 8 AM - 5 PM Eastern Standard Time

Section 53414-9

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

Section 55105-1

Pain reliever/fever reducer

Cough Suppressant

Antihistamine

Section 55106-9

Active ingredientes

(in each 30mL dose cup)

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine Succinate 12.5 mg

Section 60561-8

Other information

  • each 30 mL contains: sodium 10 mg
  • store between 58° - 86°F (15°-30° degrees C)

Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily relieves cold/flu symptoms:

  • sore throat
  • headache
  • minor aches and pain
  • fever
  • runny nose and sneezing
  • cough due to minor throat and bronchial irritation
Dosage and Administration (34068-7)
  • take only as recommended- see Overdose warning
  • use only dosing cup provided
  • keep dosing cup provided with the product
  • do not exceed 4 doses per 24 hours
  • if taking Day Time during the day and Night Time at night, limit the total to 4 doses per 24 hours
  • TBSP=tablespoon
  • mL=mililiter

adults & children 12 years and over

30 mL (2 TBSP) every 6 hours
children 4 to under 12 years ask a doctor
children under 4 years do not use

Warnings and Precautions (34071-1)

Warnings

Liver warning: This product contains acetaminophen. Sever 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 sever skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is sever, persist for more than two days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly

Section 34088-5 (34088-5)

Overdose warning: Taking more than the recommended dose (overdose) may cause serious health problems including liver damage. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • redness or swelling is present
  • symptoms do not get better within 7 days or are accompanied by a fever
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • cough lasts more than 7 days, comes back, or occurs wih fever, rash or headache that lasts. These could be signs of a serious condition.
Section 50567-7 (50567-7)

When using this product

  • do not use more than directed
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives and tranquilizers may increase drowsiness.
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use

  • if you are taking sedatives or tranquilizers
  • if you are taking the blood thinning drug warfarin.
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • a sodium restricted diet
  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs wtih smoking, asthma, chronic bronchitis or emphysema
  • trouble urinating due to enlarged prostate gland
Section 50570-1 (50570-1)

Do not use

with any other products containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist

  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's diseas), 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 sleepy
Section 51727-6 (51727-6)

Inactive ingredients: Citric acid, FD&C Blue #1, FD&C Red #40, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or Comments? 1-888-446-4753

Monday - Friday from 8 AM - 5 PM Eastern Standard Time

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Pain reliever/fever reducer

Cough Suppressant

Antihistamine

Section 55106-9 (55106-9)

Active ingredientes

(in each 30mL dose cup)

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine Succinate 12.5 mg

Section 60561-8 (60561-8)

Other information

  • each 30 mL contains: sodium 10 mg
  • store between 58° - 86°F (15°-30° degrees C)

Advanced Ingredient Data


Raw Label Data

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