NIGHTTIME SEVERE COLD AND COUGH- acetaminophen, diphenhydramine, phenylephrine powder, for solution

Nighttime Severe Cold and Cough by

Drug Labeling and Warnings

Nighttime Severe Cold and Cough by is a Otc medication manufactured, distributed, or labeled by FAMILY DOLLAR SERVICES INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each packet)

Acetaminophen, 650 mg

Diphenhydramine hydrochloride 25 mg

Phenylephrine hydrochloride 10 mg

Purposes

Pain reliever / fever reducer

Antihistamine / Cough Suppressant

Nasal Decongestant

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 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 a 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, asthma 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 lasts more than 7 days
• ▪ cough comes back or occurs with fever, rash or headache that lasts. There could be signs of a serious condition.

If pregnant or breast- feeding,

ask a health care professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. 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 6 mg
• ▪ Aspartame free, sodium free
• ▪ store at room temperature. Protect from excessive heat and moisture.

Inactive ingredients

citric acid, FD& C yellow#6, flavors, maltodextrin, potassium chloride, silica, sucralose, sucrose,

Questions or comments?

1-866-467-2748

Additional Information Listed On Other Panels

*Compare to the active ingredients in THERAFLU Nighttime Severe Cold &Cold*

NDC: 55319-451-06

NIGHTTIME

SEVERE COLD & COUGH

Acetaminophen – Pain Reliever/Fever Reducer

Diphenhydramine HCl - Antihistamine/ Cough Suppressant

Phenylephrine HCl – Nasal Decongestant

Relieves

• Cough
• Nasal Congestion
• Sore Throat Pain
• Headache
• Body Ache
• Fever
• Runny Nose
• Sneezing

6 PACKETS

Honey Lemon

Infused with Chamomile and White Tea Flavors

TAMPER EVIDENT: DO NOT USE INNER SEALED PACKET IF TORN OR BROKEN

*This product is not manufactured or distributed by GSK consumer Healthcare, distributor of TherafluNighttime Severe Cold & Cough.

Principal Display

INGREDIENTS AND APPEARANCE

NIGHTTIME SEVERE COLD AND COUGH 
acetaminophen, diphenhydramine, phenylephrine powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-451
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color		Score
Shape		Size
Flavor	HONEY, LEMON	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-451-06	6 in 1 CARTON	07/03/2023
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 final	part341	07/03/2023

Labeler - FAMILY DOLLAR SERVICES INC (024472631)