Xl-3* Day Time

Xl-3* Day Time
SPL v5
SPL
SPL Set ID 94e02be4-b8a6-422a-8f66-e6a69e924b2c
Route
ORAL
Published
Effective Date 2018-09-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg)
Inactive Ingredients
Citric Acid Monohydrate Fd&c Yellow No. 6 Glycerin Propylene Glycol Water Saccharin Sodium Sodium Behenate Sucrose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-09-01

Description

Drug Facts

Purpose

Pain reliever/fever reducer Cough Suppressant Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer

Cough Suppressant

Nasal decongestant

Dosage and Administration

Directions • take only as directed - see Overdose warning

• use dose cup or tablespoon • do not exceed 4 doses per 24 hours

• if taking Day Time during the day and Night Time at night, limit total to

4 doses per 24 hours



adults & children 12 years and over        30 mL (2 TBSP) every 4 hours



children 6 to under 12 years                 15mL (1TBSP) every 4 hours



children 4 to under 6 years                   ask a doctor



children under 4 years                         do not use

Description

Drug Facts

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 53414-9

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

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if • adult takes more than 4,000 mg of acetaminophen in 24 hours • child takes more than 5 doses in 24 hours • taken with other drugs containing acetaminophen • adult has 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, lasts 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 products containing acetaminophen (prescription or nonprescription). lf you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist • for more than10 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 disease), 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.

Other Information

• Sodium content per tablespoon: 10mg

• store at 20°-25°C (68°-77° F).

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.

Active Ingredients

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCI 5 mg

Inactive Ingredients

 citric acid, FD & C Yellow No.6, flavor, glycerin,

propylene glycol, purified water, saccharin sodium, sodium benzoate, sucrose.

Questions Or Comments?

Call weekdays from 9:30 AM to 4:30 PM EST

1-877-798-5944

When Using This Product

• do not use more than directed (see

overdose warning) • avoid alcoholic drinks

Principal Display Package

XL-3*

Day Time

Non-Drowsy Cold/Flu relief

COLD MEDICINE

• Acetaminophen - Pain Reliever/Fever Reducer

• Dextromethorphan HBr - Cough Suppressant

• Phenylephrine HCI - Nasal Decongestant

Fast Relief of:

NASAL CONGESTION

FEVER

ACHES & PAINS

SORE THROAT

COUGH                       

12 FL OZ (354 mL)    Orange Flavor

XL-3*

Day Time

Non-Drowsy Cold/Flu relief

COLD MEDICINE

• Acetaminophen - Pain Reliever/Fever Reducer

• Dextromethorphan HBr - Cough Suppressant

• Phenylephrine HCI - Nasal Decongestant

Fast Relief of:

NASAL CONGESTION

FEVER

ACHES & PAINS

SORE THROAT

COUGH                  

12 FL OZ (354 mL)          Orange Flavor

XL-3* Day Time

COLD MEDICINE

DO NOT USE IF PRINTED SHRINK BAND IS MISSING OR BROKEN

Failure to follow these warnings could result in serious consequences

Drug Facts



Active ingredients                                                                   Purpose

(in each 15 mL, 1 tablespoon)

Acetaminophen 325 mg ........................ Pain reliever/fever reducer

Dextromethorphan HBr 10 mg .........................Cough Suppressant

Phenylephrine HCI 5 mg .................................Nasal decongestant

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

→ DRUG FACTS CONTINUED ON BACK →

Distributed by:

Midway Importing, Inc.

1807 Brittmoore Road,

Houston, TX 77043 1-800-531-3873

Made in USA

                                    Peel

LR-059 REV 03             back ►

XL-3* Day Time

COLD MEDICINE

Drug Facts (continued)

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if • adult takes more than 4,000 mg of acetaminophen in 24 hours • child takes more than 5 doses in 24 hours • taken with other drugs containing acetaminophen • adult has 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, lasts 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 products containing acetaminophen (prescription or nonprescription). lf you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist • for more than10 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 disease), 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.

Ask a doctor before use if you have • liver disease

• heart disease • thyroid disease • diabetes • 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.

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

Drug Facts (continued)

When using this product • do not use more than directed (see

overdose warning) • avoid alcoholic drinks

Stop use and ask a doctor if • you get nervous, dizzy or sleepless

• symptoms get worse or last more than 5 days (children) or 7days (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.

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

Keep out of reach of children.

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.

Directions • take only as directed - see Overdose warning

• use dose cup or tablespoon • do not exceed 4 doses per 24 hours

• if taking Day Time during the day and Night Time at night, limit total to

4 doses per 24 hours

___________________________________________________________

adults & children 12 years and over │ 30 mL (2 TBSP) every 4 hours

___________________________________________________________

children 6 to under 12 years            │ 15mL (1TBSP) every 4 hours

___________________________________________________________

children 4 to under 6 years              │ ask a doctor

___________________________________________________________

children under 4 years                     │ do not use

___________________________________________________________

Other information • Sodium content per tablespoon: 10mg

• store at 20°-25°C (68°-77° F).

Inactive ingredients citric acid, FD & C Yellow No.6, flavor, glycerin,

propylene glycol, purified water, saccharin sodium, sodium benzoate, sucrose.

Questions or Comments? Call weekdays from 9:30 AM to 4:30 PM EST

1-877-798-5944



XL-3*

Day Time

Non-Drowsy Cold/Flu relief

COLD MEDICINE

• Acetaminophen - Pain Reliever/Fever Reducer

• Dextromethorphan HBr - Cough Suppressant

• Phenylephrine HCI - Nasal Decongestant

Fast Relief of:

NASAL CONGESTION

FEVER

ACHES & PAINS

SORE THROAT

COUGH                       

 6 FL OZ (177 mL)                                           Orange Flavor

Stop Use and Ask A Doctor If

• you get nervous, dizzy or sleepless

• symptoms get worse or last more than 5 days (children) or 7days (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.

Ask A Doctor Before Use If You Have

• liver disease

• heart disease • thyroid disease • diabetes • 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.

Ask A Doctor Or Pharmacist Before Use

if you are taking the blood thinning drug warfarin


Structured Label Content

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 dose cup or tablespoon • do not exceed 4 doses per 24 hours

• if taking Day Time during the day and Night Time at night, limit total to

4 doses per 24 hours



adults & children 12 years and over        30 mL (2 TBSP) every 4 hours



children 6 to under 12 years                 15mL (1TBSP) every 4 hours



children 4 to under 6 years                   ask a doctor



children under 4 years                         do not use

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 53414-9 (53414-9)

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

Purpose

Pain reliever/fever reducer

Cough Suppressant

Nasal decongestant

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if • adult takes more than 4,000 mg of acetaminophen in 24 hours • child takes more than 5 doses in 24 hours • taken with other drugs containing acetaminophen • adult has 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, lasts for more than 2 days, is

accompanied or followed by fever, headache, rash, nausea, or vomiting,

consult a doctor promptly.

Do Not Use (Do not use)

• with any other products containing acetaminophen (prescription or nonprescription). lf you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist • for more than10 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 disease), 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.

Other Information (Other information)

• Sodium content per tablespoon: 10mg

• store at 20°-25°C (68°-77° F).

Overdose Warning: (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.

Active Ingredients (Active ingredients)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCI 5 mg

Inactive Ingredients (Inactive ingredients)

 citric acid, FD & C Yellow No.6, flavor, glycerin,

propylene glycol, purified water, saccharin sodium, sodium benzoate, sucrose.

Questions Or Comments? (Questions or Comments?)

Call weekdays from 9:30 AM to 4:30 PM EST

1-877-798-5944

When Using This Product (When using this product)

• do not use more than directed (see

overdose warning) • avoid alcoholic drinks

Principal Display Package

XL-3*

Day Time

Non-Drowsy Cold/Flu relief

COLD MEDICINE

• Acetaminophen - Pain Reliever/Fever Reducer

• Dextromethorphan HBr - Cough Suppressant

• Phenylephrine HCI - Nasal Decongestant

Fast Relief of:

NASAL CONGESTION

FEVER

ACHES & PAINS

SORE THROAT

COUGH                       

12 FL OZ (354 mL)    Orange Flavor

XL-3*

Day Time

Non-Drowsy Cold/Flu relief

COLD MEDICINE

• Acetaminophen - Pain Reliever/Fever Reducer

• Dextromethorphan HBr - Cough Suppressant

• Phenylephrine HCI - Nasal Decongestant

Fast Relief of:

NASAL CONGESTION

FEVER

ACHES & PAINS

SORE THROAT

COUGH                  

12 FL OZ (354 mL)          Orange Flavor

XL-3* Day Time

COLD MEDICINE

DO NOT USE IF PRINTED SHRINK BAND IS MISSING OR BROKEN

Failure to follow these warnings could result in serious consequences

Drug Facts



Active ingredients                                                                   Purpose

(in each 15 mL, 1 tablespoon)

Acetaminophen 325 mg ........................ Pain reliever/fever reducer

Dextromethorphan HBr 10 mg .........................Cough Suppressant

Phenylephrine HCI 5 mg .................................Nasal decongestant

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

→ DRUG FACTS CONTINUED ON BACK →

Distributed by:

Midway Importing, Inc.

1807 Brittmoore Road,

Houston, TX 77043 1-800-531-3873

Made in USA

                                    Peel

LR-059 REV 03             back ►

XL-3* Day Time

COLD MEDICINE

Drug Facts (continued)

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if • adult takes more than 4,000 mg of acetaminophen in 24 hours • child takes more than 5 doses in 24 hours • taken with other drugs containing acetaminophen • adult has 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, lasts 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 products containing acetaminophen (prescription or nonprescription). lf you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist • for more than10 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 disease), 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.

Ask a doctor before use if you have • liver disease

• heart disease • thyroid disease • diabetes • 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.

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

Drug Facts (continued)

When using this product • do not use more than directed (see

overdose warning) • avoid alcoholic drinks

Stop use and ask a doctor if • you get nervous, dizzy or sleepless

• symptoms get worse or last more than 5 days (children) or 7days (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.

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

Keep out of reach of children.

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.

Directions • take only as directed - see Overdose warning

• use dose cup or tablespoon • do not exceed 4 doses per 24 hours

• if taking Day Time during the day and Night Time at night, limit total to

4 doses per 24 hours

___________________________________________________________

adults & children 12 years and over │ 30 mL (2 TBSP) every 4 hours

___________________________________________________________

children 6 to under 12 years            │ 15mL (1TBSP) every 4 hours

___________________________________________________________

children 4 to under 6 years              │ ask a doctor

___________________________________________________________

children under 4 years                     │ do not use

___________________________________________________________

Other information • Sodium content per tablespoon: 10mg

• store at 20°-25°C (68°-77° F).

Inactive ingredients citric acid, FD & C Yellow No.6, flavor, glycerin,

propylene glycol, purified water, saccharin sodium, sodium benzoate, sucrose.

Questions or Comments? Call weekdays from 9:30 AM to 4:30 PM EST

1-877-798-5944



XL-3*

Day Time

Non-Drowsy Cold/Flu relief

COLD MEDICINE

• Acetaminophen - Pain Reliever/Fever Reducer

• Dextromethorphan HBr - Cough Suppressant

• Phenylephrine HCI - Nasal Decongestant

Fast Relief of:

NASAL CONGESTION

FEVER

ACHES & PAINS

SORE THROAT

COUGH                       

 6 FL OZ (177 mL)                                           Orange Flavor

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• you get nervous, dizzy or sleepless

• symptoms get worse or last more than 5 days (children) or 7days (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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

• liver disease

• heart disease • thyroid disease • diabetes • 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.

Ask A Doctor Or Pharmacist Before Use (Ask a doctor or pharmacist before use)

if you are taking the blood thinning drug warfarin


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Raw Label Data

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