FDA Label for Xl-3 Xtreme

Other

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.

Otc - 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.

Otc - Questions

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

Principal Display Panel

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