Theraflu Severe Cold Relief Nighttime — v3

Theraflu Severe Cold Relief Nighttime

6 Views

Version

v3

Effective date

January 14, 2025

Original packager

Yes

Sections captured

18

Identifiers

Document ID
afe515bd-885b-48eb-8b79-59a2a0fff5df
Set ID
c24b9489-208c-472b-8ae5-c6e86c12e04d
Application numbers
M012
Product NDCs
0067-0105
Package NDCs
0067-0105-08
Original packager NDCs

Names & Manufacturers

Brand names
Theraflu Severe Cold Relief Nighttime
Generic names
ACETAMINOPHEN, DIPHENHYDRAMINE HCL
Manufacturer names
Haleon US Holdings LLC
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Routes
ORAL
Pharmacologic class (PE)
Pharmacologic class (EPC)
Pharmacologic class (CS)
Mechanism of action

Other identifiers

NUI
RxCUI
1294607
UNII
362O9ITL9D, TC2D6JAD40
UPC

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredients (in each 30 mL) Acetaminophen 650 mg Diphenhydramine HCl 25 mg
Ask Doctor (1)

Sequence 1

Ask a 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 Doctor Or Pharmacist (1)

Sequence 1

Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin
Do Not Use (1)

Sequence 1

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 • to sedate a child or make a child sleepy
Dosage And Administration (1)

Sequence 1

Directions • 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
Dosage And Administration Table (1)

Sequence 1

AgeDose
Adults and children 12 years of age and over30 mL
Children under 12 years of agedo not use
Inactive Ingredient (1)

Sequence 1

Inactive ingredients acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, glycerin, maltitol solution, natural and artificial flavors, propylene glycol, purified water, sodium benzoate, sodium citrate
Indications And Usage (1)

Sequence 1

Uses • temporarily relieves these symptoms 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
Keep Out Of Reach Of Children (1)

Sequence 1

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.
Package Label Principal Display Panel (1)

Sequence 1

Package/Label Principal Display Panel MULTI-SYMPTOM COLD RELIEF 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 *Temporarily controls cough to help you rest. This is not a sleep-aid. Theraflu Severe Cold Relief Nighttime 8.3 oz
Pregnancy Or Breast Feeding (1)

Sequence 1

If pregnant or breast-feeding, ask a health professional before use.
Purpose (1)

Sequence 1

Purposes Pain reliever/Fever reducer Antihistamine/Cough suppressant
Questions (1)

Sequence 1

Questions or comments? 1-855-328-5259
Spl Product Data Elements (1)

Sequence 1

Theraflu Severe Cold Relief Nighttime Acetaminophen, Diphenhydramine HCl ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN MALTITOL PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM
Spl Unclassified Section (2)

Sequence 1

Other information • each 30 mL contains: potassium 30 mg, sodium 13 mg • store at controlled room temperature 20°-25°C (68° – 77°F)

Sequence 2

Other Information Distributed by: Haleon, Warren, NJ 07059 Made in Mexico Trademarks are owned by or licensed to the Haleon group of companies. ©2024 Haleon group of companies or its licensor. Pat. Info www.productpats.com PEEL BACK HERE DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING.
Stop Use (1)

Sequence 1

Stop use and ask a doctor if • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • pain or cough 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.
Warnings (1)

Sequence 1

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 • to sedate a child or make a child sleepy Ask a 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 • pain or cough 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, 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.
When Using (1)

Sequence 1

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

OpenFDA raw payload

{'application_number': ['M012'],
 'brand_name': ['Theraflu Severe Cold Relief Nighttime'],
 'generic_name': ['ACETAMINOPHEN, DIPHENHYDRAMINE HCL'],
 'is_original_packager': [True],
 'manufacturer_name': ['Haleon US Holdings LLC'],
 'package_ndc': ['0067-0105-08'],
 'product_ndc': ['0067-0105'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['ORAL'],
 'rxcui': ['1294607'],
 'spl_id': ['afe515bd-885b-48eb-8b79-59a2a0fff5df'],
 'spl_set_id': ['c24b9489-208c-472b-8ae5-c6e86c12e04d'],
 'substance_name': ['ACETAMINOPHEN', 'DIPHENHYDRAMINE HYDROCHLORIDE'],
 'unii': ['362O9ITL9D', 'TC2D6JAD40']}