NIGHTTIME COLD AND COUGH SUGAR-FREE- acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride powder 
Cellchem Pharmaceuticals Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Nighttime Cold and Cough Sugar-Free

Drug Facts

Active Ingredients (in each packet)                                                    Purpose

Acetaminophen 650 mg.........................................Pain reliever/Fever reducer

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

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

Uses

Relieve:

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include

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 and non-prescription). 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 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

If pregnant or breast-feeding, ask a health care professional before use.

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 rash or headache that lasts. These could be signs of a serious condition.

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.

READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE.

KEEP CARTON FOR REFERENCE.

DO NOT DISCARD.

DO NOT USE IF SEALED PACKET IS TORN OR BROKEN

Directions

Do not take more than 6 packets in 24 hours unless directed by a doctor.

Age

Dose

adults and children 12 years and over

one packet

children under 12 years

do not use

Other Information

Inactive ingredients

Acesulfame potassium, aspartame, calcium phosphate dibasic, citric acid, D&C Yellow #10, maltodextrin, flavors, silicon dioxide, sodium citrate dihydrate.

Questions, Comments or Adverse Reactions?

You may report serious side effects to: +1 844-481-8884
Serious side effects can also be reported to: drugsafety@cellchempharma.ca

Distributed by:
CellChem Pharmaceuticals Inc.
Unit 1, 30 Concourse Gate
Nepean, Ontario K2E 7V7

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cartonlabel

pouch

NIGHTTIME COLD AND COUGH SUGAR-FREE 
acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73147-3111
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ASPARTAME (UNII: Z0H242BBR1)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorHONEY (honey lemon flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73147-3111-66 in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product07/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/2019
Labeler - Cellchem Pharmaceuticals Inc (111518618)
Registrant - Cellchem Pharmaceuticals Inc (111518618)
Establishment
NameAddressID/FEIBusiness Operations
Laboratoires Confab Inc241754217manufacture(73147-3111)

Revised: 1/2021
Document Id: 3e7caf31-8074-4931-a8ba-8d29d1c1591a
Set id: 01bf4051-3a70-4eaf-92cc-49db854d50a0
Version: 3
Effective Time: 20210111
 
Cellchem Pharmaceuticals Inc