XL-3 Day Time ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL APTAPHARMA INC. FDA Approved 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
FunFoxMeds box
Substance Acetaminophen
Route
ORAL
Applications
M012

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each 15 mL 1 tablespoon) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCI 5 mg
Inactive Ingredients
Inactive ingredients citric acid FD & C Yellow No.6 flavor glycerin propylene glycol purified water saccharin sodium sodium benzoate sucrose.
Strengths
15 ml 325 mg 10 mg 5 mg
Quantities
354 ml 15 ml 5 dose 4 dose 30 ml 177 ml
Treats Conditions
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

Identifiers & Packaging

Container Type BOX
UPC
0645981000368
UNII
362O9ITL9D 9D2RTI9KYH 04JA59TNSJ
Packaging

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 XL-3 Day Time 2 XL-3 6_OZ

Package Descriptions
  • 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 XL-3 Day Time 2 XL-3 6_OZ

Overview

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

Indications & Usage

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

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

Warnings & Precautions
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.
Purpose

Purpose Pain reliever/fever reducer Cough Suppressant Nasal decongestant

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.

When Using

When using this product • do not use more than directed (see overdose warning) • avoid alcoholic drinks

Stop Use & Ask a Doctor

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.

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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