Label: THERAFLU SEVERE COLD RELIEF- acetaminophen, dextromethorphan hbr, diphenphydramine hcl, guaifenesin kit
- NDC Code(s): 0067-0104-08, 0067-0105-08, 0067-0107-01
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 14, 2024
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- Official Label (Printer Friendly)
- Active ingredients (in each 30 mL) (Daytime)
- Purposes (Daytime)
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Uses (Daytime)
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- temporarily relieves these symptoms due to a cold:
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- minor aches and pains
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- minor sore throat pain
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- headache
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- cough due to minor throat and bronchial irritation
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- temporarily reduces fever
- •
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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Warnings (Daytime)
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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- more than 4,000 mg of acetaminophen in 24 hours
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
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- 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
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- in a child under 12 years of age
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- 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
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- liver disease
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- cough that occurs with too much phlegm (mucus)
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- a breathing problem such as emphysema or chronic bronchitis
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- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
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Directions (Daytime)
- •
- do not use more than directed
- •
- measure the dose correctly using the enclosed dosing cup
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- 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 (Daytime)
- Inactive ingredients (Daytime)
- Questions or comments? (Daytime)
- Active ingredients (in each 30 mL) (Nighttime)
- Purposes (Nighttime)
- Uses (Nighttime)
-
Warnings (Nighttime)
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 an MAOI, 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
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- cough that occurs with too much phlegm (mucus)
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- cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
Ask a doctor or pharmacist before use if you are
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- taking sedatives or tranquilizers
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- taking the blood thinning drug warfarin
When using this product
- •
- avoid alcoholic drinks
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- marked drowsiness may occur
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- alcohol, sedatives and tranquilizers may increase drowsiness
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- be careful when driving a motor vehicle or operating machinery
- •
- excitability may occur, especially in children
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Directions (Nighttime)
- •
- 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 (Nighttime)
- Inactive ingredients (Nighttime)
- Questions or comments? (Nighttime)
-
Additional Information
DO NOT TAKE THE DAYTIME AND NIGHTTIME PRODUCTS AT THE SAME TIME. DO NOT TAKE MORE THAN 5 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.
DO NOT TAKE A DOSE OF THE NIGHTTIME PRODUCT SOONER THAN 4 HOURS AFTER THE LAST DOSE OF THE DAYTIME PRODUCT UNLESS DIRECTED BY YOUR DOCTOR.
DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME OR TAKE MORE THAN 5 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.
PARENTS:
Learn about teen medicine abuse
TAMPER-EVIDENT INNER UNIT. DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING.
*Temporarily controls cough to help you rest. This is not a sleep aid.
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Principal Display Panel (Day/Night Combination)
MULTI-SYMPTOM COLD RELIEF
NEW FORMULA
VALUE PACK
DAYTIME FORMULA
SEVERE COLD RELIEF
MULTI-SYMPTOM COLD RELIEF
NEW FORMULA
THERAFLU
SEVERE COLD RELIEF + CHEST CONGESTION
ACETAMINOPHEN
Pain Reliever/Fever Reducer
Dextromethorphan HBr
Cough suppressant
Guaifenesin / Expectorant
DAYTIME FORMULA
Powerful formula that relieves:
/ Chest congestion
/ Thins and loosens mucus
/ Head and body ache
/ Fever
/ Cough
/ Sore throat pain
8.3 FL OZ (245.5 mL) Berry Flavor
SEVERE COLD RELIEF
HELPS YOU REST*
MULTI-SYMPTOM COLD RELIEF
NEW FORMULA
THERAFLU
SEVERE COLD RELIEF NIGHTTIME
Acetaminophen
Pain Reliever/Fever Reducer
Diphenhydramine HCl
Antihistamine/Cough Suppressant
HELPS YOU REST*
Powerful formula that relieves:
/ Cough
/ Sore throat pain
/ Head and body ache
/ Fever
/ Runny nose
/ Sneezing
8.3 FL OZ (245.5 mL) Berry Flavor
2-8.3 FL OZ (245.5 mL) BOTTLES TOTAL 16.6 FL OZ (491 mL)
USE ONLY AS DIRECTED
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INGREDIENTS AND APPEARANCE
THERAFLU SEVERE COLD RELIEF
acetaminophen, dextromethorphan hbr, diphenphydramine hcl, guaifenesin kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-0107 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0067-0107-01 1 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product 02/01/2024 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 0 BOTTLE 1 mL Part 2 0 BOTTLE 1 mL Part 1 of 2 THERAFLU SEVERE COLD RELIEF CHEST CONGESTION DAYTIME
acetaminophen, dextromethorphan hbr, guaifenesin syrupProduct Information Item Code (Source) NDC:0067-0104 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 GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg in 30 mL Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) 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) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) 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:0067-0104-08 245.5 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 Drug M012 12/01/2023 Part 2 of 2 THERAFLU SEVERE COLD RELIEF NIGHTTIME
acetaminophen, diphenhydramine hcl syrupProduct Information Item Code (Source) NDC:0067-0105 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 Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) 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) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) 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:0067-0105-08 245.5 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 Drug M012 12/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 02/01/2024 Labeler - Haleon US Holdings LLC (079944263)
