| NDC | 0067-8125-16, 0067-8127-08, 0067-8129-08 |
| Set ID | 9736ad4c-8c2e-421f-b023-f91b72d2828b |
| Category | HUMAN OTC DRUG LABEL |
| Packager | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- Theraflu® ExpressMaxTM Daytime Severe Cold & Cough
- Active ingredients (in each 30 mL)
- Purposes
- Uses
-
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 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly.
Do Not Use
- •
- in a child under 12 years of age
- •
- if you are allergic to acetaminophen
- •
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- •
- 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 drug. 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
- •
- high blood pressure
- •
- thyroid disease
- •
- diabetes
- •
- trouble urinating due to an enlarged prostate gland
- •
- cough that occurs with too much phlegm (mucus)
- •
- cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
Stop use and ask a doctor if
- •
- nervousness, dizziness, or sleeplessness occurs
- •
- fever gets worse or lasts more than 3 days
- •
- redness or swelling is present
- •
- new symptoms occur
- •
- pain, cough or nasal congestion gets worse or last more than 7 days
- •
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
-
Directions
- •
- do not use more than directed
- •
- measure the dose correctly using the enclosed dosing cup
- •
- take every 4 hours in dosing cup provided, while symptoms persist
- •
- do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor
- Age
- Dose
- adults and children 12 years of age and over
- 30 mL
- children under 12 years of age
- do not use
- Other information
- Inactive ingredients
- Questions or Comments?
- Theraflu® ExpressMaxTM Nighttime Severe Cold & Cough
- Drug Facts
- Active ingredients (in each 30 mL)
- Purposes
-
Uses
- •
- temporarily relieves these symptoms due to a cold:
- •
- minor aches and pains
- •
- minor sore throat pain
- •
- headache
- •
- nasal and sinus congestion
- •
- runny nose
- •
- sneezing
- •
- itchy nose or throat
- •
- itchy, watery eyes due to hay fever
- •
- cough due to minor throat and bronchial irritation
- •
- temporarily reduces fever
-
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 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly.
Do not use
- •
- in a child under 12 years of age
- •
- if you are allergic to acetaminophen
- •
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- •
- with any other product containing diphenhydramine, even one used on the skin
- •
- 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 drug. If you do not know if your prescription drug contains and MAO, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- •
- liver disease
- •
- heart disease
- •
- high blood pressure
- •
- thyroid disease
- •
- diabetes
- •
- glaucoma
- •
- trouble urinating due to an enlarged prostate gland
- •
- a breathing problem such as emphysema or chronic bronchitis
- •
- cough that occurs with too much phlegm (mucus)
- •
- cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
Ask a doctor or pharmacist before use if you are
- •
- taking sedatives or tranquilizers
- •
- taking the blood thinning drug warfarin
When using this product
- •
- do not exceed recommended dosage
- •
- avoid alcoholic drinks
- •
- marked drowsiness may occur
- •
- alcohol, sedatives, and tranquilizers may increase drowsiness
- •
- be careful when driving a motor vehicle or operating machinery
- •
- excitability may occur, especially in children
Stop use and ask a doctor if
- •
- nervousness, dizziness, or sleeplessness occurs
- •
- fever gets worse or lasts more than 3 days
- •
- redness or swelling is present
- •
- new symptoms occur
- •
- pain, cough or nasal congestion gets worse or lasts more than 7 days
- •
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
-
Directions
- •
- do not use more than directed
- •
- measure the dose correctly using the enclosed dosing cup
- •
- take every 4 hours in dosing cup provided, while symptoms persist.
- •
- do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor
- Age
- Dose
- adults and children 12 years of age and over
- 30 mL
- children under 12 years of age
- Do not use
- Other information
- Inactive ingredients
- Questions?
- BOXED WARNING (What is this?)
- BOXED WARNING (What is this?)
-
Principal Display Panel
NDC 0067-8125-16
THERAFLU®
ExpressMax™
VALUE PACK
Use Only as Directed
Alcohol Content: 10%
DAYTIME
NIGHTTIME
2 – 8.3 FL OZ (245.5 mL) BOTTLES TOTAL 16.6 FL OZ (491 mL)
PARENTS: Learn about teen medicine abuse
www.StopMedicineAbuse.org
TAMPER-EVIDENT INNER UNIT.
DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING
Distributed by:
Novartis Consumer Health, Inc.
Parsippany, NJ 07054-0622
©2015
12045
NDC 0067-8127-08
THERAFLU®
ExpressMax™
DAYTIME
BERRY FLAVOR
SEVERE COLD & COUGH
ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCER
DEXTROMETHORPHAN HBr-COUGH SUPPRESSANT
PHENYLEPHRINE HCl-NASAL DECONGESTANT
•NASAL CONGESTION • SORE THORAT PAIN •COUGH
•BODY ACHE • HEADACHE •FEVER
8.3 FL OZ (245.5mL)
Alcohol Content: 10%
NDC 0067-8129-08
THERAFLU®
ExpressMax™
NIGHTTIME
BERRY FLAVOR
SEVERE COLD & COUGH
ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCER
DEXTROMETHORPHAN HBl-ANTIHISTAMINE/COUGH SUPPRESSANT
PHENYLEPHRINE HCl-NASAL DECONGESTANT
•NASAL CONGESTION • HEADACHE • SORE THORAT PAIN
•RUNNY NOSE • BODY ACHE • COUGH •FEVER
8.3 FL OZ (245.5mL)
Alcohol Content: 10%
-
INGREDIENTS AND APPEARANCE
THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK
acetaminophen, dextromethorphan hbr, phenylephrine hcl and acetaminophen, diphenhydramine hcl, phenylephrine hcl kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-8125 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0067-8125-16 1 in 1 CARTON; Type 0: Not a Combination Product 07/15/2015 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 245.5 mL Part 2 1 BOTTLE 245.5 mL Part 1 of 2 THERAFLU EXPRESSMAX DAYTIME SEVERE COLD AND COUGH
acetaminophen, dextromethorphan hbr, phenylephrine hcl syrupProduct Information Item Code (Source) NDC:0067-8127 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 20 mg in 30 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 30 mL Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ALCOHOL (UNII: 3K9958V90M) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) MALTITOL (UNII: D65DG142WK) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) WATER (UNII: 059QF0KO0R) Product Characteristics Color RED Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0067-8127-08 245.5 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/15/2015 Part 2 of 2 THERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH
acetaminophen, diphenhydramine hcl, phenylephrine hcl syrupProduct Information Item Code (Source) NDC:0067-8129 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 DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg in 30 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 30 mL Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ALCOHOL (UNII: 3K9958V90M) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) MALTITOL (UNII: D65DG142WK) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) WATER (UNII: 059QF0KO0R) Product Characteristics Color RED Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0067-8129-08 245.5 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/15/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/15/2015 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
