THERAFLU SEVERE COLD RELIEF NIGHTTIME- acetaminophen, diphenhydramine hydrochloride 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 JC World Bell Wholesale Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

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 nasal and sinus congestion 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 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

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, cough or nasal congestion 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 directedtake 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 20-25°C (68-77°F). 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, f lavors, maltodextrin, silicon dioxide, sodium citrate, soy lecithin, sucrose, tribasic calcium phosphate 

Questions or comments?

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Package Labeling:

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50269-101(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 (UNII: 1Q73Q2JULR)
SOYBEAN LECITHIN (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: 50269-101-06	20 in 1 BOX	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 - JC World Bell Wholesale Co., Inc. (805257581)

Establishment
Name	Address	ID/FEI	Business Operations
JC World Bell Wholesale Co., Inc.		805257581	repack(50269-101)