XL-3* Xtreme Night Time Cold and Cough
SPL UNCLASSIFIED SECTION
Drug Facts
Active Ingredients
(in each 30 mL dose cup)Acetaminophen 650 mgrDextromethorphan HBr 30 mgDoxylamine Succinate 12.5 mg
Purpose
Pain reliever/fever reducerCough suppressantAntihistamine
Use
temporarily relieves cold/flu symptoms: • sore throatheadache • minor aches and pain • fever • runny nose andsneezing • 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 productAllergy alert: Acetaminophen may cause severe skin reactions. Symptomsmay 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 • markeddrowsiness may occur • be careful when driving a motor vehicle oroperating machinery • alcohol, sedatives and tranquilizers may increasedrowsiness.
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 SECTION
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 PoisonControl Center (1-800-222-1222) right away.Prompt medical attention is critical for adults as well as children even ifyou 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 hourschildren 4 to under 12 years ask a doctorchildren 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 SECTION
Questions or Comments? Call weekdays from 9:30 AM to 4:30 PM EST1-877-798-5944
XL-3 Xtreme Night Time Cold and Cough
XL-3* XtremeCherry FlavorNight 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 NOSEFEVERACHES & PAINSCOUGHSORE THROAT
12 FL OZ (354 mL)
XL-3* XtremeCherry FlavorNight 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 NOSEFEVERACHES & PAINSCOUGHSORE THROAT
12 FL OZ (354 mL)
XL-3* Xtreme
Cold and Cough
DO NOT USE IF PRINTED SHRINK BAND IS MISSING OR BROKENFailure 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 reducerDextromethorphan HBr 30 mg ..........................Cough suppressantDoxylamine Succinate 12.5 mg ...................................Antihistamine
Uses temporarily relieves cold/flu symptoms: • sore throatheadache • minor aches and pain • fever • runny nose andsneezing • cough due to minor throat and bronchial irritation
→ DRUG FACTS CONTINUED ON BACK →
Distributed by:Midway Importing, Inc.1807 Brittmoore Road,Houston, TX 77043 1-800-531-3873Made in USA PeelLR-060 REV 03 back ►
XL-3* Xtreme
Cold and Cough
Drug Facts (continued)
WarningsLiver 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 productAllergy alert: Acetaminophen may cause severe skin reactions. Symptomsmay 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 • avoidalcoholic drinks • excitability may occur, especially in children • markeddrowsiness may occur • be careful when driving a motor vehicle oroperating machinery • alcohol, sedatives and tranquilizers may increasedrowsiness.
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 PoisonControl Center (1-800-222-1222) right away.Prompt medical attention is critical for adults as well as children even ifyou 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 hourschildren 4 to under 12 years ask a doctorchildren 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 EST1-877-798-5944
XL-3* XtremeCherry FlavorNight 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 NOSEFEVERACHES & PAINSCOUGHSORE THROAT
6 FL OZ (177 mL)
res