XL-3 DAY TIME- acetaminophen, dextromethorphan hbr, phenylephrine hcl liquid

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts
Active ingredients (in each 15 mL, 1 tablespoon)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCI 5 mg
Purpose

Pain reliever/fever reducer
Cough Suppressant
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
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
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.
PREGNANCY 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.
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.
DOSAGE & 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
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
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

XL-3 DAY TIME
acetaminophen, dextromethorphan hbr, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76281-304
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	5 mg in 15 mL

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BEHENATE (UNII: H4W8BMK72F)
SUCROSE (UNII: C151H8M554)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 76281-304-28	354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	01/01/2018

XL-3 DAY TIME
acetaminophen, dextromethorphan hbr, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76281-306
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	5 mg in 15 mL

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BEHENATE (UNII: H4W8BMK72F)
SUCROSE (UNII: C151H8M554)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 76281-306-25	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	09/01/2018

Labeler - AptaPharma Inc. (790523323)

Registrant - AptaPharma Inc. (790523323)

Name	Address	ID/FEI	Business Operations
Establishment
AptaPharma Inc.		790523323	manufacture(76281-304, 76281-306)

XL-3 DAY TIME- acetaminophen, dextromethorphan hbr, phenylephrine hcl liquid

XL-3 Day Time by

Drug Labeling and Warnings

Drug Details [pdf]