NDC | 76281-305-28, 76281-307-25 |
Set ID | dff79e0b-edf0-4dd3-a722-fd9beecd6293 |
Category | HUMAN OTC DRUG LABEL |
Packager | AptaPharma Inc. |
Generic Name | |
Product Class | Antihistamine |
Product Number | |
Application Number | PART341 |
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Use
-
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
- Ask a doctor or pharmacist before use
- When using this product
-
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,
- 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
- Inactive ingredients
- QUESTIONS
-
XL-3 Xtreme Night Time Cold and Cough
XL-3* Xtreme
Cherry Flavor
Night TimeMulti-Symptom Cold/Flu relief
Cold and Cough
• Acetaminophen - Pain Reliever/Fever Reducer
• Dextromethorphan HBr - Cough Suppressant
• Doxylamine succinate - AntihistamineFast Relief of:
SNEEZING & RUNNY NOSE
FEVER
ACHES & PAINS
COUGH
SORE THROAT12 FL OZ (354 mL)
XL-3* Xtreme
Cherry Flavor
Night TimeMulti-Symptom Cold/Flu relief
Cold and Cough
• Acetaminophen - Pain Reliever/Fever Reducer
• Dextromethorphan HBr - Cough Suppressant
• Doxylamine succinate - AntihistamineFast Relief of:
SNEEZING & RUNNY NOSE
FEVER
ACHES & PAINS
COUGH
SORE THROAT12 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 consequencesDrug 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 ...................................AntihistamineUses 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 useOther 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
1-877-798-5944XL-3* Xtreme
Cherry Flavor
Night TimeMulti-Symptom Cold/Flu relief
Cold and Cough
• Acetaminophen - Pain Reliever/Fever Reducer
• Dextromethorphan HBr - Cough Suppressant
• Doxylamine succinate - AntihistamineFast Relief of:
SNEEZING & RUNNY NOSE
FEVER
ACHES & PAINS
COUGH
SORE THROAT6 FL OZ (177 mL)
-
INGREDIENTS AND APPEARANCE
XL-3 XTREME
acetaminophen, dextromethorphan hbr, doxylamine succinate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76281-305 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) Acetaminophen 650 mg in 30 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 30 mg in 30 mL DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 12.5 mg in 30 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCROSE (UNII: C151H8M554) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76281-305-28 354 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/01/2018 XL-3 XTREME
acetaminophen, dextromethorphan hbr, doxylamine succinate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76281-307 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) Acetaminophen 650 mg in 30 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 30 mg in 30 mL DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 12.5 mg in 30 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCROSE (UNII: C151H8M554) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76281-307-25 177 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 09/01/2018 Labeler - AptaPharma Inc. (790523323) Registrant - AptaPharma Inc. (790523323) Establishment Name Address ID/FEI Business Operations AptaPharma Inc. 790523323 manufacture(76281-305, 76281-307)