Label: THERAFLU FLU RELIEF MAX STRENGTH DAYTIME NIGHTTIME VALUE PACK- acetaminophen, dextromethorphan hbr, and acetaminophen, chlorpheniramine maleate, dextromethorphan hbr kit
- NDC Code(s): 0067-8204-01, 0067-8205-01, 0067-8206-01
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 8, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Theraflu Flu Relief Max Strength Daytime Syrup
- 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
- 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
-
Directions
- do not use more than directed
- measure the dose correctly using the enclosed dosing cup
- adults and children 12 years of age and over: take every 6 hours in dosing cup provided, while symptoms persist
- do not take more than 3 doses (90 mL) in 24 hours unless directed by a doctor
- children under 12 years of age: do not use
- 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 Flu Relief Max Strength Nighttime Syrup
- Drug Facts
- 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 a MAO, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- liver disease
- 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 the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
-
- 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
-
Directions
- do not use more than directed
- measure the dose correctly using the enclosed dosing cup
- adults and children 12 years of age and over: take every 6 hours in dosing cup provided, while symptoms persist
- do not take more than 3 doses (90 mL) in 24 hours unless directed by a doctor
- children under 12 years of age: do not use
- 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?
-
Other Safety Information
DO NOT TAKE THE DAYTIME AND NIGHTTIME PRODUCTS AT THE SAME TIME.
DO NOT TAKE MORE THAN 3 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.
PARENTS:Learn about teen medicine abuse
www.StopMedicineAbuse.org
READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE. KEEP CARTON FOR REFERENCE. DO NOT DISCARD.
TAMPER-EVIDENT INNER UNIT. DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING.
DO NOT TAKE A DOSE OF THE NIGHTTIME PRODUCT SOONER THAN 6 HOURS AFTER THE LAST DOSE OF THE DAYTIME PRODUCT UNLESS DIRECTED BY YOUR DOCTOR.
DO NOT TAKE THE DAYTIME AND NIGHTTIME PRODUCTS AT THE SAME TIME OR TAKE MORE THAN 3 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.
1-855-328-5259
Distributed by: GSK Consumer Healthcare
Warren, NJ 07059
Trademarks are owned by or licensed to the GSK group of companies.
©2021 GSK group of companies or its licensor.
Made in Canada
-
Principal Display Panel
NDC 0067-8204-01
THERAFLU
FLU RELIEF
MAX STRENGTH*
DAYTIME FORMULA
Acetaminophen
Pain Reliever/Fever Reducer
Dextromethorphan HBr
Cough Suppressant
Powerful fever fighting
formula that relieves:
/ Body ache
/ Headache
/ Sore throat pain
/ Cough
Honey & Elderberry Flavor
8.3 FL OZ (245.5mL)
NDC 0067-8205-01
THERAFLU
FLU RELIEF
MAX STRENGTH*
NIGHTTIME
HELPS YOU REST
Acetaminophen
Pain Reliever/Fever Reducer
Chlorpheniramine Maleate
Antihistamine
Dextromethorphan HBr
Cough Suppressant
Powerful fever fighting
formula that relieves:
/ Body ache
/ Headache
/ Sore throat pain
/ Cough
/ Runny nose
Honey & Elderberry Flavor
8.3 FL OZ (245.5mL)
NIGHTTIME
- 2 – 8.3 FL OZ (245.5 mL) BOTTLES TOTAL 16.6 FL OZ (491 mL) USE AS DIRECTED
- 1001529 Front Carton
-
INGREDIENTS AND APPEARANCE
THERAFLU FLU RELIEF MAX STRENGTH DAYTIME NIGHTTIME VALUE PACK
acetaminophen, dextromethorphan hbr, and acetaminophen, chlorpheniramine maleate, dextromethorphan hbr kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-8206 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0067-8206-01 1 in 1 CARTON; Type 1: Convenience Kit of Co-Package 06/27/2022 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 FLU RELIEF MAX STRENGTH DAYTIME
acetaminophen, dextromethorphan hbr syrupProduct Information Item Code (Source) NDC:0067-8204 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 1000 mg in 30 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 30 mg in 30 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) GLYCERIN (UNII: PDC6A3C0OX) HONEY (UNII: Y9H1V576FH) PEG-10 .BETA.-SITOSTERYL ETHER (UNII: B2138XJ83G) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SODIUM GLUCONATE (UNII: R6Q3791S76) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) ZINC GLUCONATE (UNII: U6WSN5SQ1Z) Product Characteristics Color Score Shape Size Flavor BERRY (Elderberry) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0067-8204-01 245.5 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 06/27/2022 Part 2 of 2 THERAFLU FLU RELIEF MAX STRENGTH NIGHTTIME
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr syrupProduct Information Item Code (Source) NDC:0067-8205 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 1000 mg in 30 mL CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 4 mg in 30 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 30 mg in 30 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) GLYCERIN (UNII: PDC6A3C0OX) HONEY (UNII: Y9H1V576FH) PEG-10 .BETA.-SITOSTERYL ETHER (UNII: B2138XJ83G) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) ZINC GLUCONATE (UNII: U6WSN5SQ1Z) Product Characteristics Color Score Shape Size Flavor BERRY (Elderberry) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0067-8205-01 245.5 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 Drug M012 06/27/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 06/27/2022 Labeler - Haleon US Holdings LLC (079944263)
