XL-3 XTREME- acetaminophen, dextromethorphan hbr, doxylamine succinate liquid

XL-3 Xtreme by

Drug Labeling and Warnings

XL-3 Xtreme by is a Otc medication manufactured, distributed, or labeled by AptaPharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

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

Purpose

Pain reliever/fever reducer
Cough suppressant
Antihistamine

Use

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

Warnings

Liver warning: This product contains acetaminophen. Severe 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 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, persists for more than two 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.
to make a child sleepy.

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 with smoking, asthma, chronic bronchitis or emphysema
trouble urinating due to enlarged prostate gland.

Ask a doctor or pharmacist before use

if you are taking sedatives or tranquilizers if you are taking the blood thinning drug warfarin.

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.

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 with fever, 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

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 recommended-see Overdose warning
Use dose cup or tablespoon (TBSP) do not exceed 4 doses per 24 hours if taking Night Time at night and Day Time during the day, limit total to 4 doses per 24 hours.

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

Other information

each 30 mL dose cup contains: sodium 45 mg
store at 20°-25°C (68°-77° F).

Inactive ingredients

citric acid, FD & C Blue No.1, FD & C Red No. 40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose.

QUESTIONS

Questions or Comments? Call weekdays from 9:30 AM to 4:30 PM EST
1-877-798-5944

XL-3 Xtreme Night Time Cold and Cough

XL-3* Xtreme
Cherry Flavor
Night Time

Multi-Symptom Cold/Flu relief

Cold and Cough
Acetaminophen - Pain Reliever/Fever Reducer
Dextromethorphan HBr - Cough Suppressant
Doxylamine succinate - Antihistamine

Fast Relief of:
SNEEZING & RUNNY NOSE
FEVER
ACHES & PAINS
COUGH
SORE THROAT

12 FL OZ (354 mL)

XL-3* Xtreme
Cherry Flavor
Night Time

Multi-Symptom Cold/Flu relief

Cold and Cough
Acetaminophen - Pain Reliever/Fever Reducer
Dextromethorphan HBr - Cough Suppressant
Doxylamine succinate - Antihistamine

Fast Relief of:
SNEEZING & RUNNY NOSE
FEVER
ACHES & PAINS
COUGH
SORE THROAT

12 FL OZ (354 mL)

XL-3* Xtreme

Cold and Cough

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 30 mL dose cup)
Acetaminophen 650 mg ........................ Pain reliever/fever reducer
Dextromethorphan HBr 30 mg ..........................Cough suppressant
Doxylamine Succinate 12.5 mg ...................................Antihistamine

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

→ 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-060 REV 03                          back ►

XL-3* Xtreme

Cold and Cough

Drug Facts (continued)

Warnings
Liver warning: This product contains acetaminophen. Severe 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 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, persists for more than two 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.
to make a child sleepy.

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 with smoking, asthma, chronic bronchitis or emphysema
trouble urinating due to enlarged prostate gland.

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

Drug Facts (continued)

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.

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 with fever, 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 recommended-see Overdose warning
Use dose cup or tablespoon (TBSP) do not exceed 4 doses per 24 hours if taking Night Time at night and Day Time during the day, limit total to 4 doses per 24 hours.
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

Other information each 30 mL dose cup contains: sodium 45 mg
store at 20°-25°C (68°-77° F).

Inactive ingredients citric acid, FD & C Blue No.1, FD & C Red No. 40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose.

Questions or Comments? Call weekdays from 9:30 AM to 4:30 PM EST
1-877-798-5944

XL-3* Xtreme
Cherry Flavor
Night Time

Multi-Symptom Cold/Flu relief

Cold and Cough
Acetaminophen - Pain Reliever/Fever Reducer
Dextromethorphan HBr - Cough Suppressant
Doxylamine succinate - Antihistamine

Fast Relief of:
SNEEZING & RUNNY NOSE
FEVER
ACHES & PAINS
COUGH
SORE THROAT

6 FL OZ (177 mL)

INGREDIENTS AND APPEARANCE

XL-3 XTREME 
acetaminophen, dextromethorphan hbr, doxylamine succinate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76281-305
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	Acetaminophen	650 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCROSE (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76281-305-28	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2018

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

XL-3 XTREME 
acetaminophen, dextromethorphan hbr, doxylamine succinate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76281-307
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	Acetaminophen	650 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCROSE (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76281-307-25	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2018

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

Labeler - AptaPharma Inc. (790523323)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(76281-305, 76281-307)