NIGHTTIME SEVERE COLD COUGH AND FLU RELIEF- acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride powder

Nighttime Severe cold cough and flu relief by

Drug Labeling and Warnings

Nighttime Severe cold cough and flu relief by is a Otc medication manufactured, distributed, or labeled by Cellchem Pharmaceuticals Inc, Laboratoires Confab Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NighttimeSevere cold cough & flu relief

Active Ingredients (in each pouch)                                                   Purpose

Acetaminophen (Extra Strength) 650 mg..................Pain reliever/Fever reducer

Diphenhydramine Hydrochloride 25 mg............Antihistamine/ Cough Suppressant

Phenylephrine Hydrochloride 10 mg......................................Nasal decongestant

Uses

• Temporarily relief of these cold and flue sysmptoms:
  • nasal and sinus congestion  
  • sore throat pain
  • headache
  • body aches and pains
  • runny nose
  • sneezing
• Temporarily relief of dry cough
• Reduce fever

INDICATIONS & USAGE

Cold and flue sysmptoms:

• nasal and sinus congestion
• sore throat pain
• headache
• body aches and pains
• runny nose
• sneezing

Warnings

Liver warning

• Acetaminophen may cause severe or possibly fatal liver damage if you take:
  • more than the recommended dose in 24 hours
  • with other drugs containing acetaminophen
  • while drinking 3 or more alcoholic drinks every day
• Symptoms of liver damage may include:
  • yellow skin or eyes
  • dark urine
  • sweating
  • nausea
  • vomiting
  • stomach pain
  • unusual tiredness
  • loss of appetite

Allergy alert

• Acetaminophen may cause serious skin reactions. Symptoms may include:
  • skin reddening
  • blisters
  • rash

If any of these symptoms occur, stop use and seek medical help right away.

Do not use

• in children under 12 years
• if you are allergic to acetaminophen, phenylephrine or any other ingredient in this product
• with any other drug containing acetaminophen, phenylephrine. 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
• with a monoamine oxidase inhibitor (MAOI) (drugs for depression or Parkinson’s disease) or for 2 weeks after stopping the MAOI drug
• with other cough and cold medications.

Ask a doctor or pharmacist before use if you  

• have:
  • heart, liver, kidney or thyroid disease 
  • high blood pressure 
  • diabetes 
  • glaucoma 
  • trouble urinating 
  • breathing problem such as emphysema or chronic bronchitis 
• take: 
  • the blood thinning drug warfarin 
  • sedatives or tranquilizers 
  • are pregnant or breastfeeding

When using this product

• drowsiness may occur 
• alcohol, sedatives and tranquilizers may increase drowsiness 
• do not drive or engage in activities requiring alertness
• avoid alcoholic drinks 
• excitability may occur, especially in children

Stop use and ask a doctor if

• symptoms worsen or last more than 7 days, or you have a fever (>38ºC) 
• pain lasts more than 5 days 
• fever lasts more than 3 days 
• sore throat pain lasts more than 2 days 
• you are: 
  • nervous 
  • dizzy 
  • can’t sleep

Keep out of reach of children.

In case of overdose, call a Poison Control Centre or get medical help right away. Quick medical attention is critical even if you do not notice any signs or symptoms

Directions

Adults and children 12 years and over:

• dissolve contents of 1 pouch in 225 mL (1 cup) of boiling water 
• may be taken every 4 to 6 hours 
• do not take more than 4 pouches in 24 hours (see Liver warning)

INFORMATION FOR PATIENTS

Other Information

• Store at 15-30°C in a dry place

Inactive ingredients

Acesulfame potassium, aspartame (contains phenylalanine), caramel color, citric acid, D&C Yellow No. 10, flavors, maltodextrin, sodium citrate, starch and sucrose

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NIGHTTIME SEVERE COLD COUGH AND FLU RELIEF 
acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73147-3109
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)
ASPARTAME (UNII: Z0H242BBR1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
STARCH, CORN (UNII: O8232NY3SJ)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	yellow (D and C Yellow 10)	Score
Shape		Size
Flavor	HONEY (honey lemon infused with white tea flavors)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73147-3109-6	10 in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product	07/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/01/2019

Labeler - Cellchem Pharmaceuticals Inc (111518618)

Registrant - Cellchem Pharmaceuticals Inc (111518618)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoires Confab Inc		241754217	manufacture(73147-3109)