Label: THERAFLU SEVERE COLD RELIEF NIGHTTIME WITH HONEY ELDERBERRY FLAVOR- acetaminophen, diphenhydramine hcl, phenylephrine hcl powder, for solution
- NDC Code(s): 0067-8212-01
- 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)
- 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.
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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 a 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.
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Ask 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
- When using this product
-
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.
- If pregnant or breast-feeding,
- Keep out of reach of children.
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Directions
- do not use more than directed
- take every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor.
Age
Dose
adults and children
12 years of age and overone packet
children under
12 years of age
do not use
- dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume 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?
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Additional Information
READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE.
KEEP CARTON FOR REFERENCE. DO NOT DISCARD.
TAMPER EVIDENT INNER UNIT
DO NOT USE IF SEALED THERAFLU PACKET IS TORN OR BROKEN
1-855-328-5259
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.
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Principal Display Panel
THERAFLU
NEW FLAVOR
MULTI - SYMPTOM COLD RELIEF
SEVERECOLD RELIEF
NIGHTTIME
HELPS YOU REST
Acetaminophen
Pain Reliever/Fever ReducerDiphenhydramine HCl
Antihistamine/Cough SuppressantPhenylephrine HCl
Nasal DecongestantHot liquid therapy
that relieves:/ Nasal and sinus congestion
/ Cough
/ Sore throat pain
/ Headache
/ Runny nose
/ FeverHoney Elderberry
6 PACKETS
PA 62000000200565 – Carton Front
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INGREDIENTS AND APPEARANCE
THERAFLU SEVERE COLD RELIEF NIGHTTIME WITH HONEY ELDERBERRY FLAVOR
acetaminophen, diphenhydramine hcl, phenylephrine hcl powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-8212 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 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) ACETIC ACID (UNII: Q40Q9N063P) ASPARTAME (UNII: Z0H242BBR1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EUROPEAN ELDERBERRY JUICE (UNII: Z4IFJ0AK1E) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) HONEY (UNII: Y9H1V576FH) ISOMALT (UNII: S870P55O2W) MALTODEXTRIN (UNII: 7CVR7L4A2D) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) SUCROSE (UNII: C151H8M554) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) TRIACETIN (UNII: XHX3C3X673) TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) Product Characteristics Color white (off-white, beige, brown) Score Shape Size Flavor HONEY (Elderberry) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0067-8212-01 6 in 1 CARTON 05/01/2023 1 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 05/01/2023 Labeler - Haleon US Holdings LLC (079944263)