Label: THERAFLU SEVERE COLD RELIEF NIGHTTIME- acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride powder
- NDC Code(s): 0067-6801-02
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 8, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each packet)
- 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.
- 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
- 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 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
- 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
- dissolve contents of one packet into 8 oz. hot water; sip while hot. Consumer entire drink within 10-15 minutes.
- 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?
-
Generic Section
TAMPER EVIDENT INNER UNIT
DO NOT USE IF SEALED THERAFLU PACKET IS TORN OR BROKEN1-855-328-5259
Distributed by: GSK Consumer Healthcare
Warren, NJ 07059
©2022 GSK group of companies or its licensor.
Trademarks are owned by or licensed to the GSK group of companies. 62000000075407HOT LIQUID THERAPY
that relieves:Nasal and sinus congestion Cough
Sore throat pain Headache
Runny nose Fever
PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.com*Temporarily controls cough to help you rest. This is not a sleep aid
CARTON
RECYCLE -
Principal Display Panel
NDC 0067-6801-02
MULTI-SYMPTOM COLD RELIEF
THERAFLU
SEVERE
COLD RELIEF
NIGHTTIME
ACETAMINOPHEN
PAIN RELIEVER/FEVER REDUCERDIPHENHYDRAMINE HCl
ANTIHISTAMINE/COUGH SUPPRESSANTPHENYLEPHRINE HCl
NASAL DECONGESTANTHELPS YOU REST*
Hot liquid therapy
that relieves:/Nasal and sinus congestion
/ Cough
/ Sore throat pain
/ Headache
/ Runny nose
/ FeverCitrus & Green Tea
6 PACKETS
-
INGREDIENTS AND APPEARANCE
THERAFLU SEVERE COLD RELIEF NIGHTTIME
acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-6801 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) ASPARTAME (UNII: Z0H242BBR1) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MALTODEXTRIN (UNII: 7CVR7L4A2D) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) SUCROSE (UNII: C151H8M554) TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) Product Characteristics Color white (white to off-white) , yellow (yellow, beige/brown granules) Score Shape Size Flavor CITRUS (Green Tea & Citrus) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0067-6801-02 6 in 1 CARTON; Type 0: Not a Combination Product 01/20/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 01/20/2022 Labeler - Haleon US Holdings LLC (079944263)
