• 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 ...
Drug Facts
(in each 30 mL dose cup)
Acetaminophen 650 mgr
Dextromethorphan HBr 30 mg
Doxylamine Succinate 12.5 mg
Pain reliever/fever reducer
Cough suppressant
Antihistamine
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
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.
• 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.
• 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.
• if you are taking sedatives or tranquilizers • if you are taking the blood thinning drug warfarin.
• 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.
• 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.
ask a health professional before use.
Keep out of reach of children.
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.
• 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
• each 30 mL dose cup contains: sodium 45 mg
• store at 20°-25°C (68°-77° F).
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
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
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution | PSN | 4 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | 4 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | 4 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | 4 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | 4 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| DOXYLAMINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76281-305-28 | XL-3 Xtreme | 354 mL in 1 BOTTLE | LIQUID | 354 | 4 | |
| 76281-307-25 | XL-3 Xtreme | 177 mL in 1 BOTTLE | LIQUID | 177 | 4 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 76281-305 | XL-3 XTREME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [APTAPHARMA INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20231231_dff79e0b-edf0-4dd3-a722-fd9beecd6293.zip |
| 76281-307 | XL-3 XTREME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [APTAPHARMA INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20231231_dff79e0b-edf0-4dd3-a722-fd9beecd6293.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 76281-305 | 76281-305-28 |
| 76281-307 | 76281-307-25 |
Every source-derived ingredient row is available through these pages.
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| XL-3 Xtreme | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | AptaPharma Inc. | dff79e0b-edf0-4dd3-a722-fd9beecd6293 | 2023-12-30 | Warnings | 76281-307-25 76281-305-28 76281-305 76281-307 76281030725 76281030528 95f58511-c4d4-4a9d-b8be-ba0b464f2e59 dff79e0b-edf0-4dd3-a722-fd9beecd6293 |
Adverse event summaries are temporarily unavailable. Other product information remains available.