THERAFLU SEVERE COLD RELIEF NIGHTTIME- acetaminophen, diphenhydramine hcl powder, for solution

Theraflu Severe Cold Relief Nighttime by

Drug Labeling and Warnings

Theraflu Severe Cold Relief Nighttime by is a Otc medication manufactured, distributed, or labeled by Haleon US Holdings LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each packet)

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Purposes

Pain reliever/Fever reducer

Antihistamine/Cough suppressant

Uses

• temporarily relieves these symptoms due to a cold:
• minor aches and pains
• minor sore throat pain
• headache
• runny nose
• sneezing
• itchy nose or throat
• itchy, watery eyes due to hay fever
• cough due to minor throat and bronchial irritation
• temporarily reduces fever

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 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.

Ask 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 sedatives or tranquilizers
• taking the blood thinning drug warfarin

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

Stop use and ask a doctor if

• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• cough comes back or occurs with rash or headache that lasts
• pain or cough gets worse or lasts more than 7 days
  These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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 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. 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

• each packet contains:potassium 10 mg, sodium 23 mg
• phenylketonurics:contains phenylalanine 13 mg per packet
• store at controlled room temperature 20 o-25 oC (68 o- 77 oF). Protect product from heat and moisture.

Inactive ingredients

acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow no.10, FD&C blue no. 1, FD&C red no. 40, maltodextrin, natural and artificial flavors, silicon dioxide, sodium citrate, soy lecithin, sucrose, tribasic calcium phosphate

Questions or comments?

1-855-328-5259

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: 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

62000000207722

Principal Display

NEW FORMULA

HALEON

THERAFLU

SEVERE COLD RELIEF

NIGHTTIME

Acetaminophen – Pain Reliever/Fever Reducer

Diphenhydramine HCl – Antihistamine/Cough Suppressant

Hot liquid therapy that relieves:

1. / Cough
   / Sore throat pain
   / Head and body ache
   / Runny nose
   / Sneezing
   / Fever

Honey Lemon Flavor

6 PACKETS

INGREDIENTS AND APPEARANCE

THERAFLU SEVERE COLD RELIEF NIGHTTIME 
acetaminophen, diphenhydramine hcl powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0067-0101
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

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)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SUCROSE (UNII: C151H8M554)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)

Product Characteristics
Color	white (white to off-white, yellow and beige)	Score
Shape		Size
Flavor	HONEY (Lemon)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0067-0101-06	6 in 1 CARTON	12/01/2023
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	12/01/2023

Labeler - Haleon US Holdings LLC (079944263)