XL-3 Xtreme ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE APTAPHARMA INC. FDA Approved 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
FunFoxMeds box
Substance Acetaminophen
Route
ORAL
Applications
M012

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredients (in each 30 mL dose cup) Acetaminophen 650 mgr Dextromethorphan HBr 30 mg Doxylamine Succinate 12.5 mg
Inactive Ingredients
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.
Strengths
30 ml 30 mg 12.5 mg
Quantities
354 ml 30 ml 4 dose 177 ml
Treats Conditions
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

Identifiers & Packaging

Container Type BOX
UPC
0645981000290 0645981000351
UNII
362O9ITL9D V9BI9B5YI2 9D2RTI9KYH
Packaging

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) res XL-3 Night Time Xtreme XL-3 Xtreme 2 XL-3 NighTime 6_OZ

Package Descriptions
  • 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) res XL-3 Night Time Xtreme XL-3 Xtreme 2 XL-3 NighTime 6_OZ

Overview

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

Indications & Usage

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

Dosage & Administration

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

Warnings & Precautions
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.
Purpose

Purpose Pain reliever/fever reducer Cough suppressant Antihistamine

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. • to make a child sleepy.

When Using

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 & Ask a Doctor

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.

Keep Out of Reach of Children

Keep out of reach of children.

Questions

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


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