Xl-3 Day Time

Xl-3 Day Time
SPL v3
SPL
SPL Set ID 2381ff41-4584-4b38-839f-f94e733f5bf2
Route
ORAL
Published
Effective Date 2026-01-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Acetaminophen (325 mg) Phenylephrine (5 mg)
Inactive Ingredients
Citric Acid Propylene Glycol Fd&c Yellow No. 6 Menthol Glycerin Water Xanthan Gum Sodium Benzoate Sorbitol Solution Sucralose

Identifiers & Packaging

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

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg


Medication Information

Warnings and Precautions

Warnings

Liver warning: This product contains acetaminophen. Sever liver damage may occur if

  • adult takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adults has 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

• ras.

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

Sore throat warning: If sore throat is sever, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Indications and Usage

Uses temporarily relieves common cold and flu symptoms:

• nasal congestion • cough due to minor throat and bronchial irritation

• sore throat • headache • minor aches and pains • fever

Dosage and Administration

Directions

  • take only as directed- 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 4 hours
children 6 to under 12 years 15 mL (1 TBSPO) every 4 hours
children 4 to under 6 years ask a doctor
children under 4 years do not use

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Section 34088-5

Overdose warning: Taking more than the recommended dose (overdose) may cause serious health problems including liver damamge. 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

  • you get nervous, dizzy or sleepless
  • symptoms get worse or last more than 5 days (children) or 7 days (adults)
  • 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.
Section 50567-7

When using this product

  • do not use more than directed (see overdose warning)
  • avoid alcoholic drinks
Section 50568-5

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Section 50569-3

Ask a doctor before use if you have

• liver disease

• heart disease

• thyroid disease

• diabete

• high blood pressure

• trouble urinating due to enlarged prostate gland

• cough accompanied by excessive phlegm (mucus)

• persistent or chronic cough such as occurs with smoking, asthma, or emphysema.

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 or 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.

Section 51727-6

Inactive ingredients: Citric acid, FD&C Yellow No 6, 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

Nasal Decongestant

Section 55106-9

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Section 60561-8

Other information

  • each 15 mL contains: sodium 5 mg
  • store between 58º - 86ºF (15º-30ºC).

Structured Label Content

Indications and Usage (34067-9)

Uses temporarily relieves common cold and flu symptoms:

• nasal congestion • cough due to minor throat and bronchial irritation

• sore throat • headache • minor aches and pains • fever

Dosage and Administration (34068-7)

Directions

  • take only as directed- 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 4 hours
children 6 to under 12 years 15 mL (1 TBSPO) every 4 hours
children 4 to under 6 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

  • adult takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adults has 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

• ras.

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

Sore throat warning: If sore throat is sever, lasts for more than 2 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 damamge. 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

  • you get nervous, dizzy or sleepless
  • symptoms get worse or last more than 5 days (children) or 7 days (adults)
  • 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.
Section 50567-7 (50567-7)

When using this product

  • do not use more than directed (see overdose warning)
  • avoid alcoholic drinks
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Section 50569-3 (50569-3)

Ask a doctor before use if you have

• liver disease

• heart disease

• thyroid disease

• diabete

• high blood pressure

• trouble urinating due to enlarged prostate gland

• cough accompanied by excessive phlegm (mucus)

• persistent or chronic cough such as occurs with smoking, asthma, or emphysema.

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 or 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.

Section 51727-6 (51727-6)

Inactive ingredients: Citric acid, FD&C Yellow No 6, 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

Nasal Decongestant

Section 55106-9 (55106-9)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Section 60561-8 (60561-8)

Other information

  • each 15 mL contains: sodium 5 mg
  • store between 58º - 86ºF (15º-30ºC).

Advanced Ingredient Data


Raw Label Data

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