Label: THERAFLU SEVERE COLD RELIEF DAYTIME- acetaminophen, dextromethorphan hbr powder, for solution
- NDC Code(s): 0067-0100-06, 0067-0100-99
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 5, 2025
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each packet)
- Purposes
- Uses
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Warnings
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
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- 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
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist.
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- 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 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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- cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
Stop use and ask a doctor if
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- fever gets worse or lasts more than 3 days
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- redness or swelling is present
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- new symptoms occur
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- pain, cough or nasal congestion gets worse or lasts more than 7 days
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- cough comes back or occurs with rash or headache that lasts
These could be signs of a serious condition.
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Directions
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- do not use more than directed
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- take every 4 hours, while symptoms persist. Do not take more than 6 packets in 24 hours unless directed by a doctor.
Age
Dose
adults and children
12 years of age and over
one packet
children under
12 years of age
do not use
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- dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
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- if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.
- Other information
- Inactive ingredients
- Questions or comments?
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Additional information
READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE.
KEEP CARTON FOR REFERENCE. DO NOT DISCARD.
PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org
TAMPER EVIDENT INNER UNIT
DO NOT USE IF SEALED THERAFLUPACKET IS TORN OR BROKEN
1-855-328-5259
Distributed by: Haleon, Warren, NJ 07059
©2023 Haleon group of companies or its licensor.
Trademarks are owned by or licensed to the Haleon group of companies.
Pat. Info www.productpats.com
62000000207707
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INGREDIENTS AND APPEARANCE
THERAFLU SEVERE COLD RELIEF DAYTIME
acetaminophen, dextromethorphan hbr powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-0100 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) ASPARTAME (UNII: Z0H242BBR1) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) MALTODEXTRIN (UNII: 7CVR7L4A2D) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SOYBEAN LECITHIN (UNII: 1DI56QDM62) SUCROSE (UNII: C151H8M554) TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) Product Characteristics Color WHITE (to off white, yellow and brown) Score Shape Size Flavor HONEY (Lemon) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0067-0100-06 6 in 1 CARTON 12/01/2023 1 1 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:0067-0100-99 1000 in 1 CONTAINER 01/01/2025 2 1 in 1 PACKET; 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 Labeler - Haleon US Holdings LLC (079944263)
